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Sample records for pharmaceutical approval update

  1. Pharmaceutical Approval Update.

    PubMed

    Fellner, Chris

    2016-01-01

    Elotuzumab (Empliciti) and ixazomib (Ninlaro) for some multiple myeloma patients; Fluad (influenza vaccine, adjuvanted) for immunization of persons 65 years of age and older; and osimertinib (Tagrisso) for certain non-small-cell lung cancers.

  2. Pharmaceutical Approval Update.

    PubMed

    Choy, Mary

    2017-01-01

    Olaratumab (Lartruvo) for the treatment of soft tissue sarcoma; bezlotoxumab (Zinplava) for use with an antibiotic to reduce recurrence of C. difficile infection; and doxylamine succinate/pyridoxine hydrochloride (Bonjesta) for the treatment of nausea and vomiting during pregnancy.

  3. Pharmaceutical approval update.

    PubMed

    Goldenberg, Marvin M

    2014-04-01

    Ibrutinib (Imbruvica) for chronic lymphocytic leukemia, tasimelteon (Hetlioz) for non-24-hour sleep-wake disorder, and anti-inhibitor coagulant complex (Feiba) to prevent or reduce bleeding in hemophilia A or B.

  4. Pharmaceutical Approval Update.

    PubMed

    Gohil, Kunj

    2015-11-01

    Evolocumab (Repatha) for patients with hypercholesterolemia whose condition has not been controlled by statins and other therapies; trifluridine/tipiracil (Lonsurf) for metastatic colorectal cancer; and blood coagulation factor VIII (Nuwiq) for adults and children with hemophilia A.

  5. Pharmaceutical approval update.

    PubMed

    Gohil, Kunj

    2014-11-01

    Naltrexone/bupropion (Contrave) for weight management; pembrolizumab (Keytruda) for melanoma; dolutegravir/abacavir/lamivudine (Triumeq) for HIV-1; and immune globulin infusion 10% (human) with recombinant human hyaluronidase (Hyqvia) for primary immunodeficiency.

  6. Pharmaceutical Approval Update.

    PubMed

    Kaufman, Michele B

    2017-10-01

    L-glutamine oral powder (Endari) for reducing the acute complications of sickle cell disease; edaravone (Radicava) for the treatment of amyotrophic lateral sclerosis; and midostaurin (Rydapt) for the treatment of acute myeloid leukemia in combination with chemotherapy.

  7. Pharmaceutical Approval Update.

    PubMed

    Choy, Mary

    2017-04-01

    Abuse-deterrent hydrocodone bitartrate (Vantrela ER) for long-term opioid treatment; etelcalcetide (Parsabiv) for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis; and deflazacort (Emflaza) for Duchenne muscular dystrophy.

  8. Pharmaceutical Approval Update.

    PubMed

    Gohil, Kunj

    2015-07-01

    Deoxycholic acid (Kybella) for submental fat; codeine polistirex/chlorpheniramine polistirex extended-release (Tuzistra XR) for coughs, allergies, and colds; ramucirumab (Cyramza) for colorectal cancer; and fluticasone furoate/vilanterol (Breo Ellipta) for asthma.

  9. Pharmaceutical approval update.

    PubMed

    Goldenberg, Marvin M

    2013-07-01

    Fluticasone furoate/vilanterol inhalation powder (Breo Ellipta) for chronic obstructive pulmonary disease; atorvastatin/ezetimibe tablets (Liptruzet) for reducing low-density lipoproteincholesterol; and radium 223 dichloride (Xofigo) injection for late-stage, castrationresistant prostate cancer.

  10. Pharmaceutical approval update.

    PubMed

    Goldenberg, Marvin M

    2014-02-01

    Simeprevir (Olysio) for chronic hepatitis C infection; coagulation Factor XIII A-subunit (recombinant) (Tretten) for bleeding prevention in congenital Factor XIII A-subunit deficiency; and umeclidinium and vilanterol inhalation powder (Anoro Ellipta) for chronic obstructive pulmonary disease.

  11. Approval times and the safety of new pharmaceuticals.

    PubMed

    Rudholm, Niklas

    2004-12-01

    This study examined the relationship between the approval times for new pharmaceuticals and the number of adverse drug reactions reported to the Swedish Medical Products Agency. Yearly time-series data concerning the number of adverse drug reactions, as well as data concerning prices and quantities sold for 25 pharmaceutical substances during the period 1972-1996 were used. The results show that shorter approval times are associated with more adverse drug reactions, but also that the effects are quite small.

  12. 78 FR 32367 - Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales, Chalfont, Kutztown and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales... of Teva Pharmaceuticals USA, Inc., in North Wales, Chalfont, Kutztown and Sellersville,...

  13. EPA Cape Cod 208 Plan 2015 Update Approval Letter

    EPA Pesticide Factsheets

    EPA approval letter re: certification by the Governor of MA that the Cape Cod WQM Plan Update is consistent with CWA section 208(b)(3) & accepted the Commonwealth’s reaffirmation of the existing designations of Cape Cod Towns as waste management agencies.

  14. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ... URBAN DEVELOPMENT FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA...) Annual renewal of each FHA lender's approval, (3) Updates to a FHA lender's approval and (4) Various... CONTACT: Leroy McKinney, Jr., Reports Management Officer, QDAM, Department of Housing and...

  15. Three Newly Approved Analgesics: An Update

    PubMed Central

    Saraghi, Mana; Hersh, Elliot V.

    2013-01-01

    Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formulation of diclofenac potassium, which is a nonsteroidal anti-inflammatory drug (NSAID), and its putative mechanism of action is through inhibition of cyclooxygenase enzymes. This novel formulation of diclofenac allows for improved absorption at lower doses. Liposomal bupivacaine is a new formulation of bupivacaine intended for single-dose infiltration at the surgical site for postoperative analgesia. Bupivacaine is slowly released from this liposomal vehicle and can provide prolonged analgesia at the surgical site. By utilizing NSAIDs and local anesthetics to decrease the transmission of afferent pain signals, less opioid analgesics are needed to achieve analgesia. Since drug-related adverse events are frequently dose related, lower doses from different drug classes may be employed to reduce the incidence of adverse effects, while producing synergistic analgesia as part of a multimodal analgesic approach to acute pain. PMID:24423420

  16. Three newly approved analgesics: an update.

    PubMed

    Saraghi, Mana; Hersh, Elliot V

    2013-01-01

    Abstract Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formulation of diclofenac potassium, which is a nonsteroidal anti-inflammatory drug (NSAID), and its putative mechanism of action is through inhibition of cyclooxygenase enzymes. This novel formulation of diclofenac allows for improved absorption at lower doses. Liposomal bupivacaine is a new formulation of bupivacaine intended for single-dose infiltration at the surgical site for postoperative analgesia. Bupivacaine is slowly released from this liposomal vehicle and can provide prolonged analgesia at the surgical site. By utilizing NSAIDs and local anesthetics to decrease the transmission of afferent pain signals, less opioid analgesics are needed to achieve analgesia. Since drug-related adverse events are frequently dose related, lower doses from different drug classes may be employed to reduce the incidence of adverse effects, while producing synergistic analgesia as part of a multimodal analgesic approach to acute pain.

  17. [Pharmaceutical and insulin therapy of diabetes mellitus type 2. Update].

    PubMed

    Siegel, E

    2015-05-01

    The prevalence of diabetes mellitus type 2 in the adult population is > 7 %. Despite new therapy options and modern insulins, the therapy remains a challenge. Especially in patients with obesity or high insulin resistance it is often difficult to achieve the necessary target values. In most cases the disease is initially asymptomatic so that the aim is the early recognition and avoidance of complications. This article provides an update on the approach options of modern therapy forms in diabetes management. The foundations of every treatment program are lifestyle interventions, including diabetes schooling. When these fail a pharmaceutical therapy must be initiated which among others is oriented to hemoglobin A1c (HbA1c). The HbA1c target value should take patient-specific circumstances into consideration and should be determined together with the patient. If no contraindications or intolerances are present, metformin is the medication of choice. Apart from metformin, the available data which can be used for guidance are limited. A combination therapy with one or two other oral or injectable medications is suitable to keep the side effects as low as possible. The advantages of other substances in individual cases could be a lower risk of hypoglycemia, reduced weight increase, oral administration and compatibility with renal insufficiency. Ultimately, insulin therapy will be necessary for many patients, either as monotherapy or in combination with other substances. Therapy decisions should be made together with the patient, taking personal preferences into consideration and should include age, body weight, comorbidities, occupational situation and compliance. The Reorganization of the Pharmaceutical Market Act represents a momentarily perceived clear barrier. In the interests of an individualized therapy and personalized disease management, a target-aimed flexibility in diabetes management should be possible in the future.

  18. 42 CFR 495.344 - Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PAPD and update, the HIT IAPD and update, and the annual HIT IAPD. 495.344 Section 495.344 Public... and update, the HIT IAPD and update, and the annual HIT IAPD. HHS will not approve the State Medicaid HIT plan, HIT PAPD and update, HIT-IAPD and update, or annual IAPD if any of these documents do...

  19. An update on pharmaceutical film coating for drug delivery.

    PubMed

    Felton, Linda A; Porter, Stuart C

    2013-04-01

    Pharmaceutical coating processes have generally been transformed from what was essentially an art form in the mid-twentieth century to a much more technology-driven process. This review article provides a basic overview of current film coating processes, including a discussion on polymer selection, coating formulation additives and processing equipment. Substrate considerations for pharmaceutical coating processes are also presented. While polymeric coating operations are commonplace in the pharmaceutical industry, film coating processes are still not fully understood, which presents serious challenges with current regulatory requirements. Novel analytical technologies and various modeling techniques that are being used to better understand film coating processes are discussed. This review article also examines the challenges of implementing process analytical technologies in coating operations, active pharmaceutical ingredients in polymer film coatings, the use of high-solids coating systems and continuous coating and other novel coating application methods.

  20. 75 FR 340 - Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... [Federal Register Volume 75, Number 2 (Tuesday, January 5, 2010)] [Notices] [Pages 340-341] [FR Doc No: E9-31315] DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1654] Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular Diagnostic Products), Chicago...

  1. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  2. Chitosan: An Update on Potential Biomedical and Pharmaceutical Applications

    PubMed Central

    Cheung, Randy Chi Fai; Ng, Tzi Bun; Wong, Jack Ho; Chan, Wai Yee

    2015-01-01

    Chitosan is a natural polycationic linear polysaccharide derived from chitin. The low solubility of chitosan in neutral and alkaline solution limits its application. Nevertheless, chemical modification into composites or hydrogels brings to it new functional properties for different applications. Chitosans are recognized as versatile biomaterials because of their non-toxicity, low allergenicity, biocompatibility and biodegradability. This review presents the recent research, trends and prospects in chitosan. Some special pharmaceutical and biomedical applications are also highlighted. PMID:26287217

  3. Chitosan: some pharmaceutical and biological aspects--an update.

    PubMed

    Singla, A K; Chawla, M

    2001-08-01

    Chitosan, a natural polysaccharide, is being widely used as a pharmaceutical excipient. It is obtained by the partial deacetylation of chitin, the second most abundant natural polymer. Chitosan comprises a series of polymers varying in their degree of deacetylation, molecular weight, viscosity, pKa etc. The presence of a number of amino groups permit chitosan to chemically react with anionic systems, thereby resulting in alteration of physicochemical characteristics of such combinations. Chitosan has found wide applicability in conventional pharmaceutical devices as a potential formulation excipient, some of which include binding, disintegrating and tablet coating properties. The polymer has also been investigated as a potential adjuvant for swellable controlled drug delivery systems. Use of chitosan in novel drug delivery as mucoadhesive, gene and peptide drug administration via the oral route as well as its absorption enhancing effects have been explored by a number of researchers. Chitosan exhibits myriad biological actions, namely hypocholesterolemic, antimicrobial and wound healing properties. Low toxicity coupled with wide applicability makes it a promising candidate not only for the purpose of drug delivery for a host of drug moieties (antiinflammatories, peptides etc.) but also as a biologically active agent. It is the endeavour of the present review to provide an insight into the biological and pharmaceutical profile of chitosan. Various investigations carried out recently are reported, although references to research performed on chitosan prior to the recent reviews have also been included, where appropriate.

  4. 78 FR 11984 - Approval and Promulgation of Implementation Plans; State of Hawaii; Update to Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; State of Hawaii; Update to...; notice of administrative change. SUMMARY: EPA is updating the materials submitted by the State of Hawaii that are incorporated by reference (IBR) into the Hawaii State Implementation Plan (SIP). The...

  5. 78 FR 78310 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...The Environmental Protection Agency (EPA) is proposing to approve revisions to the Commonwealth of Pennsylvania's (Pennsylvania) State Implementation Plan (SIP). One revision consists of an update to the SIP-approved Motor Vehicle Emissions Budgets (MVEBs) for nitrogen oxides (NOX) and volatile organic compounds (VOCs) for the 1997 8-Hour Ozone National Ambient Air Quality Standard......

  6. 77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a... IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike, P.O...

  7. 77 FR 40367 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New... DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299...

  8. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals

    PubMed Central

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Introduction Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Objectives Trends in FDA approved FDC in the period 1980–2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. Materials and Methods New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. Results During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. Conclusion FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination. PMID:26469277

  9. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

    PubMed

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

  10. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).

    PubMed

    Fujiwara, Yasuhiro; Kobayashi, Ken

    2002-05-01

    In 1996 the Japanese Diet amended the Pharmaceutical Affairs Law (PAL) and its related laws based on 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. Between 1996 and 2000, the drug approval system in Japan underwent a series of radical reforms. We describe in this paper the current system for drug approval, discuss the post-approval reexamination and reevaluation system, conditions under which development and review may be expedited, and mechanisms for approval of off-label usage. Finally, we discuss the impact of the International Conference on Harmonization (ICH) agreement on drug development and review in Japan.

  11. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs.

    PubMed

    1997-02-01

    Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.

  12. Validation and Reproducibility of the Updated French Causality Assessment Method: an Evaluation by Pharmacovigilance Centres & Pharmaceutical Companies.

    PubMed

    Théophile, Hélène; Dutertre, Jean-Paul; Gérardin, Marie; Valnet-Rabier, Marie-Blanche; Bidault, Irène; Guy, Claire; Haramburu, Françoise; Hillaire-Buys, Dominique; Méglio, Carmine; Arimone, Yannick

    2015-01-01

    Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use. A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method. To test the inter- and intra-rater reproducibility, two seniors and two juniors from a PhVC and a pharmaceutical company assessed the pairs twice with the updated method. A weighted kappa coefficient was used to measure the agreement of the two causality assessment methods with the consensual expert judgement (validity) as well as the agreement of the updated causality assessment over time (intra-rater reproducibility) and between evaluators (inter-rater reproducibility). Agreement between the current method and consensual expert judgement was fair for the PhVC team (weighted kappa [Kw] 0.33) and moderate for the pharmaceutical company team (Kw 0.41). For the updated method, agreement was better for both the PhVC (Kw 0.58) and the pharmaceutical company (Kw 0.52) teams. The inter- and intra-rater reproducibility of the updated method based on the intrinsic imputability was satisfactory overall (Kw 0.30-0.91). Discrepancies between evaluations from PhVC and pharmaceutical companies were observed with the updated method. The updated method performed better than the current one for drug causality assessment, suggesting that it should be used in routine pharmacovigilance. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  13. 76 FR 59144 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction AGENCY: Food and...

  14. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    SciTech Connect

    Lawrence, B.; Berry, M.

    1998-03-01

    The U.S. Department of Energy, Savannah River Operations Office (DOE- SR),has prepared the Site Treatment Plan (STP) for Savannah River Site (SRS) mixed wastes in accordance with RCRA Section 3021(b), and SCDHEC has approved the STP (except for certain offsite wastes) and issued an order enforcing the STP commitments in Volume I. DOE-SR and SCDHEC agree that this STP fulfills the requirements contained in the FFCAct, RCRA Section 3021, and therefore,pursuant to Section 105(a) of the FFCAct (RCRA Section 3021(b)(5)), DOE`s requirements are to implement the plan for the development of treatment capacities and technologies pursuant to RCRA Section 3021.Emerging and new technologies not yet considered may be identified to manage waste more safely, effectively, and at lower cost than technologies currently identified in the plan. DOE will continue to evaluate and develop technologies that offer potential advantages in public acceptance, privatization, consolidation, risk abatement, performance, and life-cycle cost. Should technologies that offer such advantages be identified, DOE may request a revision/modification of the STP in accordance with the provisions of Consent Order 95-22-HW.The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions (LDR). Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.

  15. Currently approved and emerging oral therapies in multiple sclerosis: An update for the ophthalmologist.

    PubMed

    Eckstein, Christopher; Bhatti, M Tariq

    2016-01-01

    Although our understanding of multiple sclerosis (MS) has grown substantially, its cause remains unknown. Nonetheless, in the past 3 decades, there have been tremendous advancements in the development of disease-modifying drugs (DMDs). In July 1993, the United States Food and Drug Administration approved the first disease-modifying drug-interferon β- and there are currently 13 medications approved for use in relapsing MS. All the early medications are administered either as a subcutaneous or intramuscular injection, and despite the clinical efficacy and safety of these medications, many patients were hampered by the inconvenience of injections and injection-related side effects. In September 2010, the first oral DMD-fingolimod-was approved. Since then, 2 additional oral DMDs (teriflunomide and dimethyl fumarate) have been approved, and several other oral medications are being evaluated in extensive MS development programs. Because of frequent ocular involvement, ophthalmologists are often involved in the care of MS patients and therefore need to be aware of the current treatment regimens prescribed by neurologists, some of which can have significant ophthalmic adverse events. We update the current advancements in the treatment of MS and discuss the published clinical data on the efficacy and safety of the currently approved and emerging oral therapies in MS.

  16. Analysis of the structural diversity, substitution patterns, and frequency of nitrogen heterocycles among U.S. FDA approved pharmaceuticals.

    PubMed

    Vitaku, Edon; Smith, David T; Njardarson, Jon T

    2014-12-26

    Nitrogen heterocycles are among the most significant structural components of pharmaceuticals. Analysis of our database of U.S. FDA approved drugs reveals that 59% of unique small-molecule drugs contain a nitrogen heterocycle. In this review we report on the top 25 most commonly utilized nitrogen heterocycles found in pharmaceuticals. The main part of our analysis is divided into seven sections: (1) three- and four-membered heterocycles, (2) five-, (3) six-, and (4) seven- and eight-membered heterocycles, as well as (5) fused, (6) bridged bicyclic, and (7) macrocyclic nitrogen heterocycles. Each section reveals the top nitrogen heterocyclic structures and their relative impact for that ring type. For the most commonly used nitrogen heterocycles, we report detailed substitution patterns, highlight common architectural cores, and discuss unusual or rare structures.

  17. Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

    PubMed

    Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

    2017-06-29

    This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

  18. [Approval of drugs by national and European agencies--sequelae for the pharmaceutical industry].

    PubMed

    Zierenberg, O

    1997-11-01

    The research-based pharmaceutical industry supports the European harmonization process for the granting of pharmaceutical registrations. In order to improve consumer protection and the therapeutic options available to physicians in comparison to nationally registered products, the harmonization must be carried out on schedule and transparently a high scientific standard. It must not lead to the adoption of all national restrictions regarding data sheets and patient leaflets. Pharmaceutical products with the same ingredients can be registered either through the national or through the European procedure. This situation can only be remedied by the harmonization of core SPCs. This process must be agreed in consultation between pharmaceutical companies and regulatory authorities. With regard to measures to avert drug risks, professional associations and the pharmaceutical companies affected should be heard by the national authorities and their arguments given due consideration. In addition, national authorities and the CPMP must coordinate their decisions before they are published. In particular, the basis of these decisions should be made clear and therapeutic alternatives should be known.

  19. 75 FR 75169 - Notice of Request for Extension of Approval of an Information Collection; Update of Nursery Stock...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-02

    ... Approval of an Information Collection; Update of Nursery Stock Regulations AGENCY: Animal and Plant Health... collection associated with regulations for the importation of nursery stock into the United States. DATES: We... regulations for the importation of nursery stock into the United States, contact Mr. Alex Belano, Branch...

  20. Safety update on the use of recombinant activated factor VII in approved indications.

    PubMed

    Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie

    2015-06-01

    This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis.

  1. The NCGC Pharmaceutical Collection: A comprehensive resource of clinically approved drugs enabling repurposing and chemical genomics

    PubMed Central

    Huang, Ruili; Southall, Noel; Wang, Yuhong; Yasgar, Adam; Shinn, Paul; Jadhav, Ajit; Nguyen, Dac-Trung; Austin, Christopher P.

    2011-01-01

    Small-molecule compounds approved for use as drugs may be “repurposed” for new indications and studied to determine the mechanisms of their beneficial and adverse effects. A comprehensive collection of all small-molecule drugs approved for human use would be invaluable for systematic repurposing across human diseases, particularly for rare and neglected diseases, for which the cost and time required for development of a new chemical entity are often prohibitive. Previous efforts to build such a comprehensive collection have been limited by the complexities, redundancies, and semantic inconsistencies of drug naming within and among regulatory agencies worldwide; a lack of clear conceptualization of what constitutes a drug; and a lack of access to physical samples. We report here the creation of a definitive, complete, and nonredundant list of all approved molecular entities as a freely available electronic resource and a physical collection of small molecules amenable to high-throughput screening. PMID:21525397

  2. The NCGC pharmaceutical collection: a comprehensive resource of clinically approved drugs enabling repurposing and chemical genomics.

    PubMed

    Huang, Ruili; Southall, Noel; Wang, Yuhong; Yasgar, Adam; Shinn, Paul; Jadhav, Ajit; Nguyen, Dac-Trung; Austin, Christopher P

    2011-04-27

    Small-molecule compounds approved for use as drugs may be "repurposed" for new indications and studied to determine the mechanisms of their beneficial and adverse effects. A comprehensive collection of all small-molecule drugs approved for human use would be invaluable for systematic repurposing across human diseases, particularly for rare and neglected diseases, for which the cost and time required for development of a new chemical entity are often prohibitive. Previous efforts to build such a comprehensive collection have been limited by the complexities, redundancies, and semantic inconsistencies of drug naming within and among regulatory agencies worldwide; a lack of clear conceptualization of what constitutes a drug; and a lack of access to physical samples. We report here the creation of a definitive, complete, and nonredundant list of all approved molecular entities as a freely available electronic resource and a physical collection of small molecules amenable to high-throughput screening.

  3. 78 FR 54200 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Maintenance Plan Update...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... Plan Update for Lake County, Indiana for Sulfur Dioxide AGENCY: Environmental Protection Agency (EPA..., Indiana sulfur dioxide (SO 2 ) maintenance area. This plan update demonstrates that Lake County...

  4. How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

    PubMed

    Bogaert, Peter; Van Keymeulen, Eveline

    2012-09-01

    This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts.

  5. Pharmaceutical and biomedical applications of chiral capillary electrophoresis and capillary electrochromatography: an update.

    PubMed

    Scriba, Gerhard K E

    2003-08-01

    Capillary electrophoresis is often considered an ideal method for the chiral analysis of compounds due to the high separation power of the technique and has therefore found widespread acceptance for the analysis of drugs and pharmaceuticals. In contrast, capillary electrochromatography is still more or less in an infancy state searching for its place among the analytical separation techniques although interesting applications have been published. The present review summarizes recent developments and applications of chiral pharmaceutical analysis by electromigration techniques published in 2002 and early 2003.

  6. Review of embryo-fetal developmental toxicity studies performed for recent FDA-approved pharmaceuticals.

    PubMed

    Ishihara-Hattori, Kana; Barrow, Paul

    2016-09-01

    Details of embryo-fetal development (EFD) studies were compiled from published FDA approval documents for 43 small molecule drugs (2014-2015) and 37 monoclonal antibodies (mAbs, 2002-2015). Anti-cancer agents were analyzed separately. Rats and rabbits were the species used for EFD studies on 93% of small molecule drugs. Overall, the rat and rabbit were equally sensitive to maternal and fetal toxicity (including teratogenicity). Dosages equivalent to more than 50-times the human exposure (or 10-times for mAbs) were frequently used, but were unnecessary for 90% of drugs. EFD studies were not required for several recently approved mAbs owing to pre-existing scientific knowledge. The cynomolgus monkey was used for developmental toxicity testing of 75% of mAbs, frequently using an ePPND study design. Studies in pregnant rodents using homologous murine antibodies supplemented or replaced monkey studies under some circumstances. Most anti-cancer small molecules and mAbs were tested for developmental toxicity in at least one species. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. 78 FR 54173 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Maintenance Plan Update...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... Plan Update for Lake County, Indiana for Sulfur Dioxide AGENCY: Environmental Protection Agency (EPA..., Indiana sulfur dioxide (SO 2 ) maintenance area. This plan update demonstrates that Lake County will... pollution control, Incorporation by reference, Intergovernmental relations, Sulfur dioxide. Dated: August...

  8. Update on pharmaceutical intervention for disorders of consciousness and agitation after traumatic brain injury in children.

    PubMed

    Suskauer, Stacy J; Trovato, Melissa K

    2013-02-01

    Responsiveness and agitation are common targets for pharmaceutical intervention after traumatic brain injury (TBI) in children. This focused review presents a critical discussion of the limited literature available on the use of medications for disorders of consciousness and agitation in children with TBI. For disorders of consciousness, evidence from several small studies supports a potential benefit of dopaminergic agents for improving responsiveness in some children with lower levels of function after TBI. Larger studies, likely requiring multicenter collaborations, are needed to more definitively address questions regarding the use of medications for responsiveness in children with TBI. The literature regarding use of pharmaceutical agents for agitation in children with TBI is even more limited. The dearth of literature regarding the effects of medications used for agitation in children with TBI highlights the need for additional basic and clinical science contributions in this area. Copyright © 2013 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  9. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

    PubMed

    Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

    Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

  10. PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes.

    PubMed

    Ramnarine, Emma; Busse, Ursula; Chassant, Franck; Colao, Marcello; Edwards, Julia; O'Donnell, Kevin; Jornitz, Maik; Munk, Morten; Seymour, Melissa; Simianu, Mihaela; Skeens, Lisa; Vinther, Anders

    2017-02-14

    The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product's lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1). But what exactly constitutes an effective PQS? And how does it support change management for PACs? This paper intends to answer these questions and guide companies to seize the opportunities outlined in ICH Q10-Annex 1, to manage product and process changes within the PQS, and downgrade the level of regulatory submission required. This is the second of a series of PDA "Points to Consider" papers on technical product lifecycle management; the first paper focused on the technical product lifecycle management strategy including communication and knowledge exchange between Marketing Authorization Holders and Health Authorities.

  11. The Effects of Pharmaceutical Excipients on Gastrointestinal Tract Metabolic Enzymes and Transporters-an Update.

    PubMed

    Zhang, Wenpeng; Li, Yanyan; Zou, Peng; Wu, Man; Zhang, Zhenqing; Zhang, Tao

    2016-07-01

    Accumulating evidence from the last decade has shown that many pharmaceutical excipients are not pharmacologically inert but instead have effects on metabolic enzymes and/or drug transporters. Hence, the absorption, distribution, metabolism, and elimination (ADME) of active pharmaceutical ingredients (APIs) may be altered due to the modulation of their metabolism and transport by excipients. The impact of excipients is a potential concern for Biopharmaceutics Classification System (BCS)-based biowaivers, particularly as the BCS-based biowaivers have been extended to class 3 drugs in certain dosage forms. The presence of different excipients or varying amounts of excipients between formulations may result in bio-inequivalence. The excipient impact may lead to significant variations in clinical outcomes as well. The aim of this paper is to review the recent findings of excipient effects on gastrointestinal (GI) absorption, focusing on their interactions with the metabolic enzymes and transporters in the GI tract. A wide range of commonly used excipients such as binders, diluents, fillers, solvents, and surfactants are discussed here. We summarized the reported effects of those excipients on GI tract phase I and phase II enzymes, uptake and efflux transporters, and relevant clinical significance. This information can enhance our understanding of excipient influence on drug absorption and is useful in designing pharmacokinetic studies and evaluating the resultant data.

  12. Update of carcinogenicity studies in animals and humans of 535 marketed pharmaceuticals.

    PubMed

    Brambilla, Giovanni; Mattioli, Francesca; Robbiano, Luigi; Martelli, Antonietta

    2012-01-01

    This survey is a compendium of information retrieved on carcinogenicity in animals and humans of 535 marketed pharmaceuticals whose expected clinical use is continuous for at least 6 months or intermittent over an extended period of time. Of the 535 drugs, 530 have the result of at least one carcinogenicity assay in animals, and 279 (52.1%) of them gave a positive response in at least one assay. Only 186 drugs (34.8%) have retrievable information on carcinogenicity in humans, and 104 of them gave to a variable extent evidence of a potential carcinogenic activity. Concerning the correlation between results obtained in animals and epidemiological findings, 58 drugs gave at least one positive result in carcinogenicity assays performed in animals and to a variable extent displayed evidence of carcinogenicity in humans, but 97 drugs tested positive in animals and were noncarcinogenic in humans or vice versa. Our findings, which are in agreement with previous studies, indicate that the evaluation of the benefit/carcinogenic risk ratio should be always made in prescribing a drug.

  13. A Comprehensive Updated Review of Pharmaceutical and Nonpharmaceutical Treatment for NAFLD

    PubMed Central

    Hossain, Newaz; Kanwar, Pushpjeet; Mohanty, Smruti R.

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with prevalence of 20–33%. NAFLD comprises a pathological spectrum. Nonalcoholic fatty liver (NAFL) is at one end and consists of simple hepatic steatosis. On the contrary, nonalcoholic steatohepatitis (NASH) consists of steatosis, inflammation, and ballooning degeneration and can progress to cirrhosis. Despite the rising incidence, definitive treatment for NAFLD, specifically NASH, has not yet been established. Lifestyle modification with dietary changes combined with regular aerobic exercise, along with multidisciplinary approach including cognitive behavior therapy, has been shown to be an effective therapeutic option, even without a significant weight loss. Pioglitazone and vitamin E have shown to be most effective in NASH patients. Surgery and weight loss medication are effective means of weight loss but can potentially worsen NASH related fibrosis. Other agents such as n-3 polyunsaturated fatty acids, probiotics, and pentoxifylline along with herbal agent such as milk thistle as well as daily intake of coffee have shown potential benefits, but further well organized studies are definitely warranted. This review focuses on the available evidence on pharmaceutical and nonpharmaceutical therapy in the treatment and the prevention of NAFLD, primarily NASH. PMID:27006654

  14. 76 FR 49391 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Rules Update

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-10

    ... how to submit comments. FOR FURTHER INFORMATION CONTACT: Christos Panos, Environmental Engineer... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION... Update AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to...

  15. 78 FR 48323 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information...--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 0 1. The authority citation for part 52 continues to...

  16. 76 FR 40602 - Paperwork Reduction Act: Updated List of Approved Information Collections and Removal of a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... amendments to the Export Administration Regulations (EAR). This rule corrects one omission of a publication... in the EAR to reflect the recent relocation of that office. Additionally, this rule updates the table of authorized information collection control numbers in ] Supplement No. 1 to part 730 of the EAR...

  17. 77 FR 35279 - Approval and Promulgation of Implementation Plans; Arizona; Update to Stage II Gasoline Vapor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... in our 1994 final rule approving an earlier version of ADWM's vapor recovery rules, we made an error... correct that error. Please see our October 3, 2011 proposed rule at pages 61063 and 61064 for additional... relative to the same vehicles using the specially formulated gasoline (referred to as ``Arizona...

  18. 76 FR 38992 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update to Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... entry ``Continuous Source Testing Manual.'' 2. Correcting the date format in the ``EPA approval date... (APA) which, upon finding ``good cause,'' authorizes agencies to dispense with public participation and... delayed effective date otherwise provided for in the APA). Today's rule simply codifies provisions which...

  19. Analysis of the landscape of biologically-derived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends.

    PubMed

    Kyriakopoulos, Sarantos; Kontoravdi, Cleo

    2013-02-14

    A thorough sort of the human drugs approved by the European Medicines Agency (EMA) between its establishment in 1995 until June 2012 is presented herein with a focus on biologically-derived pharmaceuticals. Over 200 (33%) of the 640 approved therapeutic drugs are derived from natural sources, produced via recombinant DNA technology, or generated through virus propagation. A breakdown based on production method, type of molecule and therapeutic category is presented. Current EMA approvals demonstrate that mammalian cells are the only choice for glycoprotein drugs, with Chinese hamster ovary cells being the dominant hosts for their production. On the other hand, bacterial cells and specifically Escherichia coli are the dominant hosts for protein-based drugs, followed by the yeast Saccharomyces cerevisiae. The latter is the dominant host for recombinant vaccine production, although egg-based production is still the main platform of vaccine provision. Our findings suggest that the majority of biologically-derived drugs are prescribed for cancer and related conditions, as well as the treatment of diabetes. The approval rate for biologically-derived drugs shows a strong upward trend for monoclonal antibodies and fusion proteins since 2009, while hormones, antibodies and growth factors remain the most populous categories. Despite a clear pathway for the approval of biosimilars set by the EMA and their potential to drive sales growth, we have only found approved biosimilars for three molecules. In 2012 there appears to be a slow-down in approvals, which coincides with a reported decline in the growth rate of biologics sales. Copyright © 2012 Elsevier B.V. All rights reserved.

  20. Updating a near-infrared multivariate calibration model formed with lab-prepared pharmaceutical tablet types to new tablet types in full production.

    PubMed

    Farrell, Jeremy A; Higgins, Kevin; Kalivas, John H

    2012-03-05

    Determining active pharmaceutical ingredient (API) tablet concentrations rapidly and efficiently is of great importance to the pharmaceutical industry in order to assure quality control. Using near-infrared (NIR) spectra measured on tablets in conjunction with multivariate calibration has been shown to meet these objectives. However, the calibration is typically developed under one set of conditions (primary conditions) and new tablets are produced under different measurement conditions (secondary conditions). Hence, the accuracy of multivariate calibration is limited due to differences between primary and secondary conditions such as tablet variances (composition, dosage, and production processes and precision), different instruments, and/or new environmental conditions. This study evaluates application of Tikhonov regularization (TR) to update NIR calibration models developed in a controlled primary laboratory setting to predict API tablet concentrations manufactured in full production where conditions and tablets are significantly different than in the laboratory. With just a few new tablets from full production, it is found that TR provides reduced prediction errors by as much as 64% in one situation compared to no model-updating. TR prediction errors are reduced by as much as 51% compared to local centering, another calibration maintenance method. The TR updated primary models are also found to predict as well as a full calibration model formed in the secondary conditions. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. 75 FR 42455 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... that FDA withdraw approval of the applications pursuant to the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is...

  2. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.

    PubMed

    Soares, Kelen Carine Costa; Santos, Gustavo Mendes Lima; Gelfuso, Guilherme M; Gratieri, Tais

    2015-11-01

    This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.

  3. Fusion strategies for selecting multiple tuning parameters for multivariate calibration and other penalty based processes: A model updating application for pharmaceutical analysis.

    PubMed

    Tencate, Alister J; Kalivas, John H; White, Alexander J

    2016-05-19

    New multivariate calibration methods and other processes are being developed that require selection of multiple tuning parameter (penalty) values to form the final model. With one or more tuning parameters, using only one measure of model quality to select final tuning parameter values is not sufficient. Optimization of several model quality measures is challenging. Thus, three fusion ranking methods are investigated for simultaneous assessment of multiple measures of model quality for selecting tuning parameter values. One is a supervised learning fusion rule named sum of ranking differences (SRD). The other two are non-supervised learning processes based on the sum and median operations. The effect of the number of models evaluated on the three fusion rules are also evaluated using three procedures. One procedure uses all models from all possible combinations of the tuning parameters. To reduce the number of models evaluated, an iterative process (only applicable to SRD) is applied and thresholding a model quality measure before applying the fusion rules is also used. A near infrared pharmaceutical data set requiring model updating is used to evaluate the three fusion rules. In this case, calibration of the primary conditions is for the active pharmaceutical ingredient (API) of tablets produced in a laboratory. The secondary conditions for calibration updating is for tablets produced in the full batch setting. Two model updating processes requiring selection of two unique tuning parameter values are studied. One is based on Tikhonov regularization (TR) and the other is a variation of partial least squares (PLS). The three fusion methods are shown to provide equivalent and acceptable results allowing automatic selection of the tuning parameter values. Best tuning parameter values are selected when model quality measures used with the fusion rules are for the small secondary sample set used to form the updated models. In this model updating situation, evaluation of

  4. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation

    NASA Astrophysics Data System (ADS)

    Ayoub, Bassam M.

    2016-11-01

    New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12 μg mL- 1 for both drugs using simultaneous equation with LOD values equal to 0.20 μg mL- 1 and 0.19 μg mL- 1, LOQ values equal to 0.59 μg mL- 1 and 0.58 μg mL- 1 for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10 μg mL- 1. The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.

  5. Disposal Notifications and Quarterly Membership Updates for the Utility Solid Waste Group Members’ Risk-Based Approvals to Dispose of PCB Remediation Waste Under Title 40 of the Code of Federal Regulations Section 761.61(c)

    EPA Pesticide Factsheets

    Disposal Notifications and Quarterly Membership Updates for the Utility Solid Waste Group Members’ Risk-Based Approvals to Dispose of Polychlorinated Biphenyl (PCB) Remediation Waste Under Title 40 of the Code of Federal Regulations Section 761.61(c)

  6. 42 CFR 495.344 - Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Approval of the State Medicaid HIT plan, the HIT... Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Requirements Specific to the Medicaid Program § 495.344 Approval of the State Medicaid HIT plan, the HIT PAPD...

  7. 42 CFR 495.344 - Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Approval of the State Medicaid HIT plan, the HIT... Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Requirements Specific to the Medicaid Program § 495.344 Approval of the State Medicaid HIT plan, the HIT PAPD...

  8. 42 CFR 495.344 - Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Approval of the State Medicaid HIT plan, the HIT... Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Requirements Specific to the Medicaid Program § 495.344 Approval of the State Medicaid HIT plan, the HIT PAPD...

  9. 42 CFR 495.344 - Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Approval of the State Medicaid HIT plan, the HIT... Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Requirements Specific to the Medicaid Program § 495.344 Approval of the State Medicaid HIT plan, the HIT PAPD...

  10. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2014-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

  11. Pharmaceutical research and development.

    PubMed

    McKercher, P L

    1992-01-01

    Some aspects of pharmaceutical research and development (R&D) are reviewed. The viability of major pharmaceutical manufacturers depends on their research and thus they commit substantial resources to R&D programs. Major pharmaceutical manufacturers in the United States employ about 40,000 R&D personnel, and worldwide pharmaceutical R&D expenditures reached $24 billion in 1990. The pharmaceutical industry is one of the most profitable; however, increasing prices of their products are often associated with increasing R&D costs, ignoring the many positive attributes of R&D. The Council on Competitiveness has recently proposed reforms in the approval process for new drugs, including accelerated approval, external review, and international cooperation. These reforms would help to preserve an R&D capability and a relatively unregulated pharmaceutical industry. Pharmaceutical R&D has made many important contributions, including increased life expectancy, the internationally competitive position of the US industry, and a positive balance of trade. However, a misunderstanding of the role of R&D could encourage development of policies and legislation detrimental to pharmaceutical R&D.

  12. Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

    PubMed

    Hartford, Craig G; Petchel, Kasia S; Mickail, Hani; Perez-Gutthann, Susana; McHale, Mary; Grana, John M; Marquez, Paula

    2006-01-01

    Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to a maturing of drug safety risk management. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also permitted a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development. In this paper, we review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development and provide author opinion on these guidelines' potential drug safety implications. We discuss the possible evolution of a pharmaceutical industry model to respond to these guidelines; a view on multidisciplinary safety management teams is provided to encourage refinement of safety-signal identification and risk assessment early in drug development and to communicate important safety concerns to internal research efforts, patients, investigators and regulators. We further describe these functions in the context of the complexities of vulnerable populations, including the example of medicines research for paediatric populations. We also discuss the special role of epidemiology in pre-approval drug development and the impact on epidemiological

  13. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    PubMed Central

    Pinkerton, JoAnn V.; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

  14. Poet Marion Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  15. Poet Alexandria Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Alexandria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  16. Poet North Manchester Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-North Manchester, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable

  17. Poet Portland Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves the petition, with modifications, from Poet Biorefining-Portland, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  18. Kansas Ethanol Lyons Approval

    EPA Pesticide Factsheets

    This update August 9, 2016 letter from EPA approves, with modifications, the petition from Kansas Ethanol, LLC, Lyons facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel

  19. Poet Laddonia Approval

    EPA Pesticide Factsheets

    This update Auugust 9, 2016 letter from EPA approves with modifications, the petition from Poet Biorefining Laddonia, Poet Laddonia Facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act f

  20. Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra

    NASA Astrophysics Data System (ADS)

    Abdel Ghany, Maha F.; Hussein, Lobna A.; Magdy, Nancy; Yamani, Hend Z.

    2016-03-01

    Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky-Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1-30 and 10-35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%-100.49% with low value of RSD% (< 1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process.

  1. Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra.

    PubMed

    Abdel Ghany, Maha F; Hussein, Lobna A; Magdy, Nancy; Yamani, Hend Z

    2016-03-15

    Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky-Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1-30 and 10-35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%-100.49% with low value of RSD% (<1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process.

  2. Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product.

    PubMed

    Peinado, Antonio; Hammond, Jonathan; Scott, Andrew

    2011-01-05

    Pharmaceutical companies are progressively adopting and introducing the principles of Quality by Design with the main purpose of assurance and built-in quality throughout the whole manufacturing process. Within this framework, a Partial Least Square (PLS) model, based on Near Infrared (NIR) spectra and humidity determinations, was built in order to determine in-line the drying end point of a fluidized bed process. The in-process method was successfully validated following the principles described within The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH Q2 (r1) - Validation of Analytical Procedures: Text and Methodology. However, in some aspects, the cited guidelines were not appropriate to in-process methods developed and validated exclusively with in-line samples and implemented in dynamic systems, such as drying processes. In this work, a customized interpretation of guidelines has been adopted which provided the framework of evidence to support a validated application. The application has been submitted to the United States Food and Drug Administration (FDA) and The European Medicines Agency (EMA) during applications for grant of licences. Representatives from these Regulatory Authorities have specifically reviewed this novel application during on-site inspections, and have subsequently approved both the product and this application. Currently, the NIR method is implemented as a primary in-line method to control the drying end point in real-time (to below a control limit of not greater than 1.2% w/w) for commercial production batches of an approved, solid, oral-dose medicine. The implementation of this in-process method allows real-time control with benefits including a reduction in operation time and labour; sample handling and waste generation; and a reduced risk to product quality in further unit operations due to improved consistency of intermediate output at this stage. To date

  3. Systematic review and meta-analysis of the risk of microbial contamination of parenteral doses prepared under aseptic techniques in clinical and pharmaceutical environments: an update.

    PubMed

    Austin, P D; Hand, K S; Elia, M

    2015-12-01

    Administration of parenteral doses with microbial contamination can lead to infective morbidity or death. To test whether aseptic preparation of parenteral doses or additives to sterile doses undertaken in dedicated pharmaceutical rather than clinical environments reduces the risk of microbial dose contamination. Data identified from a systematic review were examined using random effects meta-analyses, and t-tests were used to compare dose contamination frequencies. In all, 16,552 doses from 34 studies (33 records) were identified. For all the data combined there was a significantly higher frequency of contamination of doses prepared in clinical than in pharmaceutical environments {3.7% [95% confidence interval (CI): 2.2, 6.2; N = 10,272 doses] vs 0.5% (95% CI: 0.1, 1.6; N = 6280 doses); P = 0.007}. Contamination of doses was significantly higher when prepared as individual lots than as part of a batch in pharmaceutical environments [2.1% (95% CI: 0.7, 5.8; N = 168 doses) vs 0.2% (95% CI: 0.1, 0.9; N = 6112 doses); P = 0.002]. There was a significantly higher frequency of dose contamination if additions were made to sterile parenteral doses in clinical environments [risk ratio: 2.121 (95% CI: 1.093, 4.114); P = 0.026]. The overall quality of the studies was judged to be low. Reported rates of parenteral dose contamination were orders of magnitude higher than accepted reference standards, which may increase infection risk. The limited evidence on contamination rates supports dose preparation in pharmaceutical rather than clinical environments, and does not support batch preparation in clinical environments. Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  4. QbD implementation and Post Approval Lifecycle Management (PALM).

    PubMed

    Ohage, Ettore; Iverson, Raquel; Krummen, Lynne; Taticek, Ron; Vega, Maria

    2016-09-01

    Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1-3]. An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Lifecycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  5. Pharmaceutical Psychology.

    ERIC Educational Resources Information Center

    Dolinsky, Donna

    1979-01-01

    Defines areas that could comprise pharmaceutical psychology. The discussion includes a review of literature, outline of areas in pharmacy in which psychologists could become involved, description of a project involving the application of psychology to pharmacy, and analysis of the concept of pharmaceutical psychology. A 99-item bibliography is…

  6. FDA-Approved HIV Medicines

    MedlinePlus

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with ... 2007 Pharmacokinetic Enhancers Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine ...

  7. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2012.

    PubMed

    Rawal, Bina; Deane, Bryan R

    2015-01-01

    The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2012. This is an extension of the previously reported study of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, which found that over three-quarters of all these trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2012, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2014. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2014 (end of survey). Of the completed trials associated with 23 new medicines licensed to 17 different companies in 2012, results of 90% (307/340) had been disclosed within 12 months, and results of 92% (312/340) had been disclosed by 31 July 2014. The disclosure rate within 12 months of 90% suggests the industry is now achieving disclosure in a timely manner more consistently than before. The overall disclosure rate at study end of 92% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2012.

  8. [Pharmaceuticals: a strategic national industry].

    PubMed

    Hollender, Louis

    2004-01-01

    Asked by Mme Nicole Fontaine, Delegate Minister of Industry, to help the government with its ongoing reflections on pharmaceutical industrial strategy, and the necessary autonomy of our country in the face of major commercial threats, a working group of the French National Academy of Medicine consulted representatives of five French and two foreign major drug companies. Their statements can be classified in four categories:--the first concerns new medications, which must be approved successively by three commissions, whose opinions are often delayed and influenced by economic considerations;--second, public and private research are both insufficient and are sometimes hindered by procedural restrictions,--third, the pharmaceutical industry is unable to deal with frequent and unforseeable political upheavals,--France does not adequately recognize the strategic importance of the pharmaceutical industry in the national economy. The Academy makes several recommendations: the French pharmaceutical industry should be considered as a national priority, the strategic importance of national pharmaceutical companies should be recognized, a multi-annual contract should be signed with manufacturers, clinical trials should be facilitated in France, relationships between the national pharmaceutical industry and public research structures should be reinforced, and an inter-ministerial Council on Pharmaceuticals should be created. This study was supplemented by a survey of veterinary medications, the results and conclusions of which are very similar to those outlined above for human medicines.

  9. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013.

    PubMed

    Deane, Bryan R; Sivarajah, Jacintha

    2017-03-01

    The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2013. This is an extension of two previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012. The original study found that over a three year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The extension study (2012 approvals) showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% by the end of the study. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2013, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2015. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2015 (end of survey). Of the completed trials associated with 34 new medicines licensed to 24 different companies in 2013, results of 90% (484/539) had been disclosed within 12 months, and results of 93% (500/539) had been disclosed by 31 July 2015. The disclosure rate within 12 months of 90% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 93% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated

  10. Plecanatide: First Global Approval.

    PubMed

    Al-Salama, Zaina T; Syed, Yahiya Y

    2017-03-03

    Plecanatide (Trulance(TM)) is an oral guanylate cyclase-C agonist that is being developed by Synergy Pharmaceuticals for the treatment of gastrointestinal disorders, such as chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It is a synthetic analogue of human uroguanylin, a 16 amino acid peptide that regulates ion and fluid transport in the gastrointestinal tract. In January 2017, plecanatide received its first global approval in the USA for the treatment of adult patients with CIC. Plecanatide is undergoing phase III investigation in IBS-C. This article summarizes the milestones in the development of plecanatide leading to this first approval in CIC.

  11. New treatment paradigms in psoriatic arthritis: an update on new therapeutics approved by the U.S. Food and Drug Administration.

    PubMed

    Felquer, Maria L Acosta; Soriano, Enrique R

    2015-03-01

    The purpose of this study is to give an overview of the new treatments approved by the U.S. Food and Drug Administration (FDA) for use in psoriatic arthritis (PsA). FDA has approved three new drugs for PsA: Certolizumab-pegol: a PEGylated Fc-free tumour necrosis factor inhibitor (TNFi); ustekinumab: an anti interleukin (IL)-12 and IL-23 mAb; and apremilast and oral phosphodiesterase 4 inhibitor. On well designed and extensive developing programmes, all three drugs proved to be effective for the treatment of most PsA manifestations, including peripheral arthritis, skin involvement, enthesitis, dactylitis, quality of life and radiographic progression in patients failing traditional disease modifying drugs (DMARDs) and TNFi. Safety profile of all three drugs seems to be reassuring until now, although long-term data are still not available. Although Certolizumab-pegol is likely to be placed among the other TNFi, ustekinumab and apremilast, due to lower efficacy on arthritis, are being more frequently used as second-line therapy after TNFi failure, especially among rheumatologists. There are new therapeutic options approved for the treatment of PsA. For the first time, well proved effective therapies with a different mechanism of action than the inhibition of TNF alpha are available for the treatment of this progressive disease.

  12. 75 FR 67623 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Volatile Organic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-03

    ... Protection Agency (Illinois EPA) submitted amendments to its pharmaceutical manufacturing rules for approval... today and what is the purpose of this action? EPA is approving revisions to Illinois' pharmaceutical...) * * * (186) On July 17, 2009, Illinois submitted amendments to its pharmaceutical manufacturing rules...

  13. Pharmaceutical virtue.

    PubMed

    Martin, Emily

    2006-06-01

    In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

  14. 34 CFR 668.55 - Updating information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., DEPARTMENT OF EDUCATION STUDENT ASSISTANCE GENERAL PROVISIONS Verification and Updating of Student Aid... time during the award year, the applicant must update FAFSA information, except when the update is due... ability to pay. Approved by the Office of Management and Budget under control number 1845-0041) (Authority...

  15. An update on the validation of whole slide imaging systems following FDA approval of a system for a routine pathology diagnostic service in the United States.

    PubMed

    Boyce, B F

    2017-08-24

    Pathologists have used light microscopes and glass slides to interpret the histologic appearance of normal and diseased tissues for more than 150 years. The quality of both microtomes used to cut tissue sections and microscopes has improved significantly during the past few decades, but the process of rendering diagnoses has changed little. By contrast, major advances in digital technology have occurred since the introduction of hand held electronic devices, including the development of whole slide imaging (WSI) systems with software packages that can convert microscope images into virtual (digital) slides that can be viewed on computer monitors and via the internet. To date, however, these technological developments have had minimal impact on the way pathologists perform their daily work, with the exception of using computers to access electronic medical records and scholarly web sites for pertinent information to assist interpretation of cases. Traditional practice is likely to change significantly during the next decade, especially since the Federal Drug Administration in the USA has approved the first WSI system for routine diagnostic practice. I review here the development and slow acceptance of WSI by pathology departments. I focus on recent advances in validation of WSI systems that is required for routine diagnostic reporting of pathology cases using this technology.

  16. EPA Approves New Mexicos Clean Air Plan

    EPA Pesticide Factsheets

    DALLAS - (Sept. 29, 2015) The U.S. Environmental Protection Agency (EPA) recently approved updates to New Mexico's clean air plan. New Mexico's plan meets federal requirements for implementation, maintenance and enforcement of the 2010 sulfur dioxid

  17. Pharmaceutical Analysis as a Branch of Pharmaceutics

    ERIC Educational Resources Information Center

    Connors, Kenneth A.

    1977-01-01

    Pharmaceutical analysis is incorporated into the pharmaceutics component of the undergraduate curriculum at the University of Wisconsin. Many collaborative demonstrations, lectures, and laboratory experiments can illustrate the close relationship between analysis and modern pharmacy practice. (Author/LBH)

  18. Alirocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Alirocumab (Praluent®) is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi that has been approved in the US as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a down regulator of liver low-density lipoprotein (LDL)-receptors-thereby increasing the ability of the liver to bind LDL-cholesterol (LDL-C) and reducing levels of LDL-C in blood. It has been shown to reduce LDL-C levels in patients with hypercholesterolaemia, including HeFH, both as monotherapy and in conjunction with statin therapy. This article summarizes the milestones in the development of alirocumab leading to this first approval.

  19. Linaclotide: first global approval.

    PubMed

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  20. Resuscitation and rescue of the pharmaceutical detail: a prescriber-drug representative collaboration.

    PubMed

    Kale, Scott A; Barkin, Robert L

    2009-01-01

    The traditional pharmaceutical detail must be revised to meet current prescriber presentation and interaction needs. Best practice and evidence-based clinical strategies demands, an expanded database describing prescribable pharmaceutical therapies. We present a format for the structure of a functional database for pharmaceuticals and a means by which the data can be introduced, updated and instituted.

  1. Multiple Sclerosis: An Update.

    PubMed

    Faguy, Kathryn

    2016-05-01

    Multiple sclerosis (MS) is the most common disabling neurologic condition in young adults and imposes high financial and quality of life costs on patients, their families, and society. Yet, developments in the battle against MS include new treatments to slow its progression and updated diagnostic criteria that can accelerate diagnosis and effective treatment. This article offers a review and update on the disease, focusing on risk factors and possible causes, symptoms, forms of MS, diagnostic criteria and tools, and the expanding array of approved treatments. It also reports on the skyrocketing cost of MS drugs, misdiagnosis, and special patient populations with MS.

  2. Elosulfase alfa: first global approval.

    PubMed

    Sanford, Mark; Lo, Jin Han

    2014-04-01

    Elosulfase alfa (Vimizim™) is a recombinant form of N-acetylgalactosamine-6-sulfatase (GALNS) that was developed by BioMarin Pharmaceutical Inc. as an enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Patients with MPS IVA have a GALNS deficiency, which results in serious musculoskeletal, cardiorespiratory and other system disturbances. Elosulfase alfa was approved by the US FDA on 14 February 2014 for the treatment of MPS IVA. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recently recommended that elosulfase alfa be approved for use in the EU in the same indication. Within the last year, the manufacturer has also filed applications for approval for the use of elosulfase alfa in MPS IVA in Brazil, Australia, Canada and Mexico. This article summarizes the milestones in the development of elosulfase alfa leading to its first global approval in MPS IVA.

  3. Planetary Nomenclature: An Overview and Update

    NASA Astrophysics Data System (ADS)

    Gaither, T.; Hayward, R. K.; Blue, J.; Gaddis, L.; Schulz, R.; Aksnes, K.; Burba, G.; Consolmagno, G.; Lopes, R. M. C.; Masson, P.; Sheehan, W.; Smith, B. A.; Williams, G.; Wood, C.

    2017-06-01

    This contribution is an update for the planetary science community on the status of planetary nomenclature, its purpose and rules, the process for submitting name requests, and the IAU approval process.

  4. AAP Updates Recommendations on Car Seats

    MedlinePlus

    ... Size Email Print Share AAP Updates Recommendations on Car Seats Page Content Article Body Children should ride ... of approved car safety seats. Healthy Children Radio: Car Seat Safety Dennis Durbin, MD, FAAP, lead author ...

  5. CATL (Cooperative Approval Tire List) Update

    DTIC Science & Technology

    2010-03-25

    GOVERNMENT ITEM NO. TEST REFERENCE NO. TGD2 2 E/L X2.10.74RA/RB ACTS-CATL-TOR-03-02 TGS2 2 TG X2.10.75RA/RB ACTS-CATL-TOR-03-02 STL3 2 E/L X2.10.76RA...Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 2 TOPICS AGENDA • 2010 CATL 1922 TESTS • 2011 CATL 1922 TESTS • 2010 CATL 1923 TESTS • CATL 1922... TEST TIRE SPECIFICATION • TEST LABS • CATL 1922 ADDS/DELETES BY QUALIFICATION EXTENSION (APRIL 09 – PRESENT) • CATL 1923 ADDS/DELETES BY QUALIFICATION

  6. Pharmaceutical salts: a summary on doses of salt formers from the Orange Book.

    PubMed

    Saal, C; Becker, A

    2013-07-16

    Over half of the active pharmaceutical ingredients currently approved within the US are pharmaceutical salts. Selection of suitable pharmaceutical salts is carried out during late research or early development phase. Therefore several properties of different pharmaceutical salts of a new chemical entity are assessed during salt screening and salt selection. This typically includes physico-chemical behavior, dissolution rate and pharmacokinetics of a pharmaceutical salt. Beyond these properties also toxicological aspects have to be taken into account. As a starting point for a toxicological assessment we present an overview of the usage of pharmaceutical salts as described in the FDA's Orange Book including maximum daily doses for the most important administration routes.

  7. Invisible pollution: the impact of pharmaceuticals in the water supply.

    PubMed

    Strauch, Kimberly A

    2011-12-01

    During the past decade, interest in the public and environmental health effects of trace levels of pharmaceuticals and personal care products in the water supply has evolved. Although most pharmaceuticals are tested for human safety and efficacy prior to marketing and distribution, the potential for adverse effects in nontarget populations exposed to minute environmental medication doses has not been established. Several recent studies have demonstrated adverse effects from longstanding, low-dose exposures in both aquatic and terrestrial wildlife, although human toxicity related to trace levels of pharmaceuticals in the water supply remains unknown. This article provides a brief overview of the routes through which pharmaceuticals are introduced into the environment; a description of the effects of longstanding, low-dose exposures in aquatic and terrestrial animals, including human health effects; an update on the current regulations and solutions regarding pharmaceutical disposal practices; and a discussion of implications for reducing pharmaceuticals in the environment for occupational health nurses and other allied health professionals.

  8. 76 FR 10246 - Updating Fire Safety Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-24

    ... AFFAIRS 38 CFR Parts 17 and 59 RIN 2900-AN57 Updating Fire Safety Standards AGENCY: Department of Veterans... for VA approval of such facilities, including standards for fire safety and heating and cooling.... Comments should indicate that they are submitted in response to ``RIN 2900-AN57--Updating Fire...

  9. Exercise-induced bronchoconstriction update-2016.

    PubMed

    Weiler, John M; Brannan, John D; Randolph, Christopher C; Hallstrand, Teal S; Parsons, Jonathan; Silvers, William; Storms, William; Zeiger, Joanna; Bernstein, David I; Blessing-Moore, Joann; Greenhawt, Matthew; Khan, David; Lang, David; Nicklas, Richard A; Oppenheimer, John; Portnoy, Jay M; Schuller, Diane E; Tilles, Stephen A; Wallace, Dana

    2016-11-01

    The first practice parameter on exercise-induced bronchoconstriction (EIB) was published in 2010. This updated practice parameter was prepared 5 years later. In the ensuing years, there has been increased understanding of the pathogenesis of EIB and improved diagnosis of this disorder by using objective testing. At the time of this publication, observations included the following: dry powder mannitol for inhalation as a bronchial provocation test is FDA approved however not currently available in the United States; if baseline pulmonary function test results are normal to near normal (before and after bronchodilator) in a person with suspected EIB, then further testing should be performed by using standardized exercise challenge or eucapnic voluntary hyperpnea (EVH); and the efficacy of nonpharmaceutical interventions (omega-3 fatty acids) has been challenged. The workgroup preparing this practice parameter updated contemporary practice guidelines based on a current systematic literature review. The group obtained supplementary literature and consensus expert opinions when the published literature was insufficient. A search of the medical literature on PubMed was conducted, and search terms included pathogenesis, diagnosis, differential diagnosis, and therapy (both pharmaceutical and nonpharmaceutical) of exercise-induced bronchoconstriction or exercise-induced asthma (which is no longer a preferred term); asthma; and exercise and asthma. References assessed as relevant to the topic were evaluated to search for additional relevant references. Published clinical studies were appraised by category of evidence and used to document the strength of the recommendation. The parameter was then evaluated by Joint Task Force reviewers and then by reviewers assigned by the parent organizations, as well as the general membership. Based on this process, the parameter can be characterized as an evidence- and consensus-based document.

  10. Modeling choice behavior for new pharmaceutical products.

    PubMed

    Bingham, M F; Johnson, F R; Miller, D

    2001-01-01

    This paper presents a dynamic generalization of a model often used to aid marketing decisions relating to conventional products. The model uses stated-preference data in a random-utility framework to predict adoption rates for new pharmaceutical products. In addition, this paper employs a Markov model of patient learning in drug selection. While the simple learning rule presented here is only a rough approximation to reality, this model nevertheless systematically incorporates important features including learning and the influence of shifting preferences on market share. Despite its simplifications, the integrated framework of random-utility and product attribute updating presented here is capable of accommodating a variety of pharmaceutical marketing and development problems. This research demonstrates both the strengths of stated-preference market research and some of its shortcomings for pharmaceutical applications.

  11. Globalization and the pharmaceutical industry revisited.

    PubMed

    Busfield, Joan

    2003-01-01

    This survey of the pharmaceutical industry at the beginning of the 21st century updates some of the information provided in Claudio Tarabusi and Graham Vickery's survey, "Globalization in the Pharmaceutical Industry," published in the International Journal of Health Services in 1998, which was largely based on data up to 1993. However, the purpose of the present article differs from that of Tarabusi and Vickery, which covered a wide range of aspects of the industry relevant to globalization but did not explicitly address the question of the extent to which the industry could be described as globalized. After looking at the industry in some detail, the author directly confronts the question of the appropriateness of the use of the term "globalization" for characterizing the directions in which the pharmaceutical industry has been moving.

  12. [Practical application of the charter of pharmaceutical sales visit].

    PubMed

    Leroy, B; Uhart, M; Lajoinie, A; Maire, P; Ducher, M; Bourguignon, L

    2012-11-01

    Visits from pharmaceutical representatives are controlled in France by regulations, but also by a Charter of good practice. The goal of this study was to measure compliance to the conditions of this charter by participating pharmaceutical companies. An assessment grid was drafted to determine compliance to interdictions and obligations concerning the information provided during visits from pharmaceutical representatives. We studied 20 visits from pharmaceutical representatives. All of the documents and obligatory information were only provided in 5% of cases. During 80% of these meetings, the pharmaceutical representatives made a comparison with competitor's drugs, which was associated with negative remarks in 44% of cases. The pharmaceutical representatives promoted cases of use outside those, which had received marketing approval in 35%. Gifts or samples were offered at the end of these meetings in 20% of cases. Prohibited practices were observed in a total of 85% of cases. This study shows that meetings are respected by pharmaceutical representatives in terms of regulations related to donations. In opposite, there is a very low compliance concerning the proper use of the drug, whether to provide official documentation, to give information respectful of other pharmaceutical companies or to promote the proper use. Our results suggest that, at present hospital visits by pharmaceutical representatives do not respect the commitments made by the pharmaceutical industry, and do not make it possible to ensure that honest information is provided to favor the proper use of drugs. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  13. 76 FR 51049 - Notice of Submission of Proposed Information Collection to OMB; FHA Lender Approval, Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... URBAN DEVELOPMENT Notice of Submission of Proposed Information Collection to OMB; FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports by FHA Approved Lenders AGENCY: Office of the Chief... information is required for: (1) FHA Lender Approval; (2) Annual renewal of each FHA Lender's Approval;...

  14. An industry update: the latest developments in therapeutic delivery.

    PubMed

    Simpson, Iain

    2017-02-01

    This Industry Update covers the period from 1 October through to 31 October 2016, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw several news items covering drug-delivery devices, including a new sensor to monitor and support the use of inhalers; launch in the UK of a new autoinjector for Cimzia(®), UCB's rheumatoid arthritis drug; and approval of Roche's Lucentis(®) in a prefilled syringe. Research was also published to show the value of continuous blood pressure monitoring in dementia management. Astellas announced the acquisition of German pharmaceutical company Ganymed while Sunovion completed its purchase of Cynapsus. A new EU-funded collaboration was announced looking at the value of PET-based biomarkers in Alzheimer's disease. GSK gained USA approval for its shingles vaccine, but Novo Nordisk and Sanofi received complete response letters from the US FDA, requiring further information before regulatory review of their drug submissions can be completed. The UK's NICE concluded that a drug marketed by BMS to treat a common type of lung cancer was not cost-effective and Cornell University announced results showing that its nanoparticle technology, originally developed as a tumor biomarker, could be effective in directly treating the disease.

  15. Industry Update: The latest developments in therapeutic delivery.

    PubMed

    Rosenmayr-Templeton, Louise

    2013-11-01

    This article provides a snapshot of the news stories from the world of therapeutic delivery in the period 1-31 August 2013. During this month, the Boards of Amgen and Onyx Pharmaceuticals gave their approval to the purchase by Amgen of Onyx's outstanding shares in a deal worth US$10.4 billion, or $9.7 billion net of estimated Onyx cash. The deal, said to be the fifth largest involving a biotechnology company, is expected to close in Q4 2013 subject to customary closing conditions and regulatory approval. August also saw the publication of a reflection paper on the coating of nanomedicines by the European Medicines Agency's Committee for Medicinal Products for Human Use. This paper highlights the key considerations for the development of nanomedicine and nanosimilars (nanomedicines that are claimed to be similar to a reference nanomedicine) and makes recommendations with regard to the quality control and assurance of such products. As ever, the Industry Update is based mainly on information from press releases and company websites.

  16. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

    PubMed

    Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

    2012-12-01

    1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  17. Obinutuzumab: first global approval.

    PubMed

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  18. EPA Approves Revisions to Pueblo of Pojoaque Water Quality Standards

    EPA Pesticide Factsheets

    DALLAS - (Dec. 16, 2015) The U.S. Environmental Protection Agency (EPA) approved revisions to the Pueblo of Pojoaque's water quality standards. The Clean Water Act revisions included revised aquatic life criteria and updates to technical references.

  19. Living with Fibromyalgia, Drugs Approved to Manage Pain

    MedlinePlus

    ... Consumers Home For Consumers Consumer Updates Living with Fibromyalgia, Drugs Approved to Manage Pain Share Tweet Linkedin ... syndrome, and depression. back to top What Causes Fibromyalgia? Scientists believe that the condition may be due ...

  20. The UK pharmaceutical market. An overview.

    PubMed

    Towse, A

    1996-01-01

    The National Health Service (NHS) accounts for more than 98% of the UK prescription medicines market, which is the sixth largest pharmaceutical market in the world. Most of this market is driven by the UK's approximately 35,000 general practitioners (GPs). It is an open market, with most leading foreign pharmaceutical companies having a strong presence. While the growth rate of this market has been decelerating, it remains one of the fastest growing components of NHS expenditure. The NHS does not operate any kind of national reimbursement list, but the UK government has adopted several means to keep medicines expenditure under control. These include cash incentives and constraints for GPs relating to expenditure on medicines, individual quarterly updates on GP prescribing, the publication of a list of medicines that cannot be prescribed by GPs, the switching of some prescription-only medicines to over-the-counter medicines, and a co-payment system. The main form of economic regulation in the UK, however, remains the Pharmaceutical Price Regulation Scheme (PPRS). This limits the rate-of-return on capital attributable to medicines sales to the NHS, with the intended rate-of-return being equal to that of UK industry overall. The pharmaceutical industry has generally performed relatively well in the UK market, managing to preserve incentives to innovation. This reflects the fact that UK GPs have been able to maintain their clinical freedom, as well as government recognition of the economic contribution made by the pharmaceutical industry. Current issues of interest in the UK pharmaceutical market context include the future of the PPRS, the debates over the imposition of a national formulary and generic substitution, and over parallel trade, the potential impact of managed-care protocols and computer-based prescribing on pharmaceutical expenditures, and possible political changes.

  1. 'Linkage' pharmaceutical evergreening in Canada and Australia.

    PubMed

    Faunce, Thomas A; Lexchin, Joel

    2007-06-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines.

  2. 'Linkage' pharmaceutical evergreening in Canada and Australia

    PubMed Central

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

  3. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

  4. Pharmaceutical cocrystals: an overview.

    PubMed

    Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary

    2011-10-31

    Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper.

  5. A tool for corporate decision making about cognitive pharmaceutical services.

    PubMed

    Tipton, D J

    2001-01-01

    To present and discuss the models, theories, ideas, and frameworks that corporate decision makers would apply to the implementation of cognitive pharmaceutical services. Large chains and integrated delivery networks dominate the pharmacy marketplace. As a result, in many instances implementing cognitive pharmaceutical services, or expanding their delivery, first requires approval of a corporate decision maker, often not a pharmacist, who is schooled in marketing, management, and finance, and who necessarily views proposals for cognitive pharmaceutical services from those frames of reference. This article focuses on the following six marketing and management questions that corporate decision makers likely want answered before approving and funding the implementation of cognitive pharmaceutical services: (1) What is our product? (2) Who will pay, and what is the price? (3) Is there a market, and can it be reached? (4) What procedures must be put in place? (5) Who will deliver the service? (6) Where are the services to be delivered, and how is the facility to be presented? For a pharmacy manager charged with bringing cognitive pharmaceutical services to the marketplace, consideration of the issues detailed here meets a reasonable test of due diligence in committing human, financial, and organizational resources. It is natural for a pharmacist to look at cognitive pharmaceutical services through a professional lens. It is just as natural for a corporate decision marker to look at cognitive pharmaceutical services through a marketing and management lens. Unless both lenses are put together, one gets only half the picture.

  6. Does brand differentiate pharmaceuticals?

    PubMed

    Bednarik, Josef

    2005-12-01

    Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

  7. Biological and Pharmaceutical Nanomaterials

    NASA Astrophysics Data System (ADS)

    Kumar, Challa S. S. R.

    2006-01-01

    This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.

  8. Microbial factories for recombinant pharmaceuticals

    PubMed Central

    Ferrer-Miralles, Neus; Domingo-Espín, Joan; Corchero, José Luis; Vázquez, Esther; Villaverde, Antonio

    2009-01-01

    Most of the hosts used to produce the 151 recombinant pharmaceuticals so far approved for human use by the Food and Drug Administration (FDA) and/or by the European Medicines Agency (EMEA) are microbial cells, either bacteria or yeast. This fact indicates that despite the diverse bottlenecks and obstacles that microbial systems pose to the efficient production of functional mammalian proteins, namely lack or unconventional post-translational modifications, proteolytic instability, poor solubility and activation of cell stress responses, among others, they represent convenient and powerful tools for recombinant protein production. The entering into the market of a progressively increasing number of protein drugs produced in non-microbial systems has not impaired the development of products obtained in microbial cells, proving the robustness of the microbial set of cellular systems (so far Escherichia coli and Saccharomyces cerevisae) developed for protein drug production. We summarize here the nature, properties and applications of all those pharmaceuticals and the relevant features of the current and potential producing hosts, in a comparative way. PMID:19317892

  9. NASA Update

    NASA Image and Video Library

    2010-04-08

    "NASA Update" program with NASA Administrator Charles Bolden, NASA Deputy Administrator Lori Garver and NASA Acting Asistant Administrator for Public Affairs Bob Jacobs as moderator, NASA Headquarters, Thursday, April 8, 2010 in Washington. Photo Credit: (NASA/Bill Ingalls)

  10. Pharmaceutical Education in Nigeria.

    ERIC Educational Resources Information Center

    Oyegbile, F. Rachel

    1988-01-01

    Nigeria has six pharmacy schools, most offering graduate programs. The undergraduate program is being expanded from four to five years. Although behavioral and clinical sciences are offered, emphasis is on the pharmaceutical sciences. Overall, pharmaceutical education is oriented toward hospice practice. (Author/MSE)

  11. Pharmaceutical Education in Poland

    ERIC Educational Resources Information Center

    Furmanowa, Miroslawa; Borke, Mitchell L.

    1978-01-01

    The content and organization of Poland's system of pharmaceutical education is described. Tables are presented of the subjects of the basic studies curriculum and the following areas of specialization: applied pharmacy, pharmaceutical analysis, clinical analysis, drug technology, herbal pharmacy, and bioanalysis and environmental studies. (SW)

  12. Radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

    Dám, A. M.; Gazsó, L. G.; Kaewpila, S.; Maschek, I.

    1996-03-01

    Product specific doses were calculated for pharmaceuticals to be radiation treated. Radio-pasteurization dose were determined for some heat sensitive pharmaceutical basic materials (pancreaton, neopancreatin, neopancreatin USP, duodenum extract). Using the new recommendation (ISO standards, Method 1) dose calculations were performed and radiation sterilization doses were determined for aprotinine and heparine Na.

  13. Pharmaceutical Education in Nigeria.

    ERIC Educational Resources Information Center

    Oyegbile, F. Rachel

    1988-01-01

    Nigeria has six pharmacy schools, most offering graduate programs. The undergraduate program is being expanded from four to five years. Although behavioral and clinical sciences are offered, emphasis is on the pharmaceutical sciences. Overall, pharmaceutical education is oriented toward hospice practice. (Author/MSE)

  14. 75 FR 38757 - Approval and Promulgation of Implementation Plans; State of Iowa

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-06

    ...; FRL-9170-5] Approval and Promulgation of Implementation Plans; State of Iowa AGENCY: Environmental... revision to the Iowa State Implementation Plan (SIP). The purpose of this revision is to update the Polk... updates to the Iowa statewide rules previously approved by EPA and will ensure consistency between...

  15. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

  16. 78 FR 26301 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Approval of Texas Low...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ...EPA is proposing approval of a revision to the Texas State Implementation Plan (SIP) concerning the Texas Low Emission Diesel (TxLED) Fuel rules. The revisions clarify existing definitions and provisions, revise the approval procedures for alternative diesel fuel formulations, add new registration requirements, and update the rule to reflect the current program status because the rule is now fully implemented. This SIP revision meets statutory requirements.

  17. 78 FR 26255 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Approval of Texas Low...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ...EPA is granting direct final approval of a revision to the Texas State Implementation Plan (SIP) concerning the Texas Low Emission Diesel fuel rules. The revisions clarify existing definitions and provisions, revise the approval procedures for alternative diesel fuel formulations, add new registration requirements, and update the rule to reflect the current program status because the rule is now fully implemented. This SIP revision meets statutory requirements.

  18. A survey of reimbursement practices of private health insurance companies for pharmaceuticals not covered under the Pharmaceutical Benefits Scheme 2008.

    PubMed

    Lingaratnam, Senthil M; Kirsa, Sue W; Mellor, James D; Jackson, John; Crellin, Wallace; Fitzsimons, Michael; Zalcberg, John R

    2011-05-01

    To describe the current practices and policy of Australian private health insurance (PHI) companies with respect to cover for pharmaceuticals not subsidised under the Pharmaceutical Benefits Scheme (PBS). A 2008 review of web-published policy statements for top-level hospital and comprehensive general treatment insurance, and survey of reimbursement practices by way of questionnaire, of 31 Australian-registered, open-membership PHI companies. Description of the level of pharmaceutical cover and important considerations identified by PHI companies for funding non-PBS pharmaceuticals through benefit entitlements or ex-gratia payments. Nine of thirty-one PHI companies (29%) provided responses accounting for ~60% market share of PHI. The majority of smaller PHI firms either declined participation or did not respond. The maximum limits offered for non-PBS pharmaceuticals, under comprehensive general treatment insurance, varied significantly and typically did not adequately cover high-cost pharmaceuticals. Some companies occasionally offered ex-gratia payments (or discretionary payments in excess of the policyholder's entitlement benefits) for high cost-pharmaceuticals. Factors considered important in their decision to approve or reject ex-gratia requests were provided. All results were de-identified. There is little consistency across PHI companies in the manner in which they handle requests for high-cost pharmaceuticals in excess of the defined benefit limits. Such information and processes are not transparent to consumers.

  19. Pharmaceutical policy in China.

    PubMed

    Sun, Qiang; Santoro, Michael A; Meng, Qingyue; Liu, Caitlin; Eggleston, Karen

    2008-01-01

    Contradictory goals plague China's pharmaceutical policy. The government wants to develop the domestic pharmaceutical industry and has used drug pricing to cross-subsidize public hospitals. Yet the government also aims to control drug spending through price caps and profit-margin regulations to guarantee access even for poor patients. The resulting system has distorted market incentives, increased consumers' costs, and financially rewarded inappropriate prescribing, thus undermining public health. Pharmaceuticals account for about half of total health spending in China, representing 43 percent of spending per inpatient episode and 51 percent of spending per outpatient visit. Yet some essential medicines are unavailable or of questionable quality.

  20. Amorphous pharmaceutical solids.

    PubMed

    Vranić, Edina

    2004-07-01

    Amorphous forms are, by definition, non-crystalline materials which possess no long-range order. Their structure can be thought of as being similar to that of a frozen liquid with the thermal fluctuations present in a liquid frozen out, leaving only "static" structural disorder. The amorphous solids have always been an essential part of pharmaceutical research, but the current interest has been raised by two developments: a growing attention to pharmaceutical solids in general, especially polymorphs and solvates and a revived interest in the science of glasses and the glass transition. Amorphous substances may be formed both intentionally and unintentionally during normal pharmaceutical manufacturing operations. The properties of amorphous materials can be exploited to improve the performance of pharmaceutical dosage forms, but these properties can also give rise to unwanted effects that need to be understood and managed in order for the systems to perform as required.

  1. Paying for pharmaceutical registration in developing countries.

    PubMed

    Kaplan, Warren A; Laing, Richard

    2003-09-01

    Fees charged by drug regulatory authorities (DRAs) may be used as a policy instrument to speed up regulatory approval, to encourage retention of quality staff and to stimulate introduction of generics versus new chemical entities. Often, the cost recovery function of these registration fees is not related to the true cost of the pharmaceutical regulatory process. In this paper, we scaled new drug registration fees of various DRAs to indices of economic development - the GNP per capita and the total government health expenditure per capita. Based on our analyses of 34 countries, most DRA registration fees for new drug applications for developing/non-OECD countries are less than the current GNP/capita of that country or are about US dollars 5000 for each US dollars 1000 spent per capita on healthcare. At present, each US dollars 1000 new drug registration fee for the developing/non-OECD countries analyzed corresponds to a total pharmaceutical market share of about US dollars 85 million. Our analyses further suggest little relationship between DRA registration fees and drug approval times in developing countries. The situation is complex, however, as policy tradeoffs are important to consider. Differential registration fees, presumably designed to encourage locally produced versus imported products, may violate international trade regulations. Moreover, certain DRA registration fees may provide perverse incentives for the pharmaceutical industry. Developing countries should require that DRA registration fees be based on accurate accounting of the cost of services provided. At present levels, these fees could be increased without disincentive to the pharmaceutical industry. For new drug registration fees, our analyses suggest that developing countries could charge between 1-5 times their GNP per capita or between US dollars 17000 and US dollars 80000 for each US dollars 1000 spent per capita on healthcare.

  2. Ecotoxicology of human pharmaceuticals.

    PubMed

    Fent, Karl; Weston, Anna A; Caminada, Daniel

    2006-02-10

    Low levels of human medicines (pharmaceuticals) have been detected in many countries in sewage treatment plant (STP) effluents, surface waters, seawaters, groundwater and some drinking waters. For some pharmaceuticals effects on aquatic organisms have been investigated in acute toxicity assays. The chronic toxicity and potential subtle effects are only marginally known, however. Here, we critically review the current knowledge about human pharmaceuticals in the environment and address several key questions. What kind of pharmaceuticals and what concentrations occur in the aquatic environment? What is the fate in surface water and in STP? What are the modes of action of these compounds in humans and are there similar targets in lower animals? What acute and chronic ecotoxicological effects may be elicited by pharmaceuticals and by mixtures? What are the effect concentrations and how do they relate to environmental levels? Our review shows that only very little is known about long-term effects of pharmaceuticals to aquatic organisms, in particular with respect to biological targets. For most human medicines analyzed, acute effects to aquatic organisms are unlikely, except for spills. For investigated pharmaceuticals chronic lowest observed effect concentrations (LOEC) in standard laboratory organisms are about two orders of magnitude higher than maximal concentrations in STP effluents. For diclofenac, the LOEC for fish toxicity was in the range of wastewater concentrations, whereas the LOEC of propranolol and fluoxetine for zooplankton and benthic organisms were near to maximal measured STP effluent concentrations. In surface water, concentrations are lower and so are the environmental risks. However, targeted ecotoxicological studies are lacking almost entirely and such investigations are needed focusing on subtle environmental effects. This will allow better and comprehensive risk assessments of pharmaceuticals in the future.

  3. Quality Control of Pharmaceuticals

    PubMed Central

    Levi, Leo; Walker, George C.; Pugsley, L. I.

    1964-01-01

    Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed. PMID:14199105

  4. Microcap pharmaceutical firms: linking drug pipelines to market value.

    PubMed

    Beach, Robert

    2012-01-01

    This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms.

  5. NASA Update

    NASA Image and Video Library

    2011-02-15

    NASA Deputy Administrator Lori Garver listens as NASA Administrator Charles Bolden answers a question during a NASA Update on Tuesday, Feb. 15, 2011, at NASA Headquarters in Washington. Bolden and Garver took the time discuss the agency’s fiscal year 2012 budget request and to take questions from employees. Photo Credit: (NASA/Bill Ingalls)

  6. NASA Update

    NASA Image and Video Library

    2011-02-15

    NASA Administrator Charles F. Bolden Jr., answers questions during a NASA Update on, Tuesday, Feb. 15, 2011, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and NASA Deputy Administrator Lori Garver took the time discuss the agency’s fiscal year 2012 budget request and to take questions from employees. Photo Credit: (NASA/Bill Ingalls)

  7. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr. left, and Deputy Administrator Lori Garver are seen during their first NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  8. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr. speaks during his first NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator, was joined by Deputy Administrator Lori Garver where they took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  9. NASA Update

    NASA Image and Video Library

    2011-02-15

    NASA Administrator Charles F. Bolden Jr., and Deputy Administrator Lori Garver deliver a NASA Update on, Tuesday, Feb. 15, 2011, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time discuss the agency’s fiscal year 2012 budget request and to take questions from employees. Photo Credit: (NASA/Bill Ingalls)

  10. NASA Update.

    NASA Image and Video Library

    2011-02-15

    NASA Deputy Administrator Lori Garver answers questions during a NASA Update on, Tuesday, Feb. 15, 2011, at NASA Headquarters in Washington. Garver and NASA Administrator Charles Bolden took the time discuss the agency’s fiscal year 2012 budget request and to take questions from employees. Photo Credit: (NASA/Bill Ingalls)

  11. NASA Update

    NASA Image and Video Library

    2011-02-15

    NASA Deputy Associate Administrator for the Office of Communications Bob Jacobs moderates the NASA Update program, Tuesday, Feb. 15, 2011 at NASA Headquarters in Washington. NASA's 12th Administrator Charles Bolden and Deputy Administrator Lori Garver took the time discuss the agency’s fiscal year 2012 budget request and to take questions from employees. Photo Credit: (NASA/Bill Ingalls)

  12. Update '98.

    ERIC Educational Resources Information Center

    Mock, Karen R.

    1998-01-01

    Updates cases and issues previously discussed in this regular column on human rights in Canada, including racism and anti-Semitism, laws on hate crimes, hate sites on the World Wide Web, the use of the "free speech" defense by hate groups, and legal challenges to antiracist groups by individuals criticized by them. (DSK)

  13. Update '98.

    ERIC Educational Resources Information Center

    Mock, Karen R.

    1998-01-01

    Updates cases and issues previously discussed in this regular column on human rights in Canada, including racism and anti-Semitism, laws on hate crimes, hate sites on the World Wide Web, the use of the "free speech" defense by hate groups, and legal challenges to antiracist groups by individuals criticized by them. (DSK)

  14. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Safety analysis report updating. 72.248 Section 72.248... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder... section, the final safety analysis report (FSAR) to assure that the information included in the...

  15. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  16. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  17. 78 FR 4766 - Adoption of Updated EDGAR Filer Manual

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-23

    ... COMMISSION 17 CFR Parts 232, 239, 249, 269, 274 Adoption of Updated EDGAR Filer Manual AGENCY: Securities and...) Filer Manual and related rules to reflect updates to the EDGAR system. The revisions are being made...: Effective Date: January 23, 2013. The incorporation by reference of the EDGAR Filer Manual is approved...

  18. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

  19. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

  20. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:27729682

  1. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26405328

  2. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421513

  3. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421469

  4. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421499

  5. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421565

  6. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26912923

  7. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421552

  8. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25673896

  9. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477570

  10. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26823622

  11. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25717211

  12. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421539

  13. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477618

  14. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24623873

  15. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26405346

  16. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26448675

  17. Cell-Based Veterinary Pharmaceuticals - Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union.

    PubMed

    Faltus, Timo; Brehm, Walter

    2016-01-01

    Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.

  18. Cell-Based Veterinary Pharmaceuticals – Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union

    PubMed Central

    Faltus, Timo; Brehm, Walter

    2016-01-01

    Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965

  19. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Deputy Administrator Lori Garver, right, looks on as NASA Administrator Charles F. Bolden Jr. speaks during his first NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  20. NASA Update

    NASA Image and Video Library

    2009-07-20

    Alan Ladwig, Senior Advisor to the NASA Administrator, introduces Administrator Charles F. Bolden Jr. and Deputy Administrator Lori Garver at a NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, the agency's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  1. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Deputy Administrator Lori Garver, second right on stage, speaks as NASA Administrator Charles F. Bolden Jr. looks on during a NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  2. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr. is seen through a television camera monitor during his first NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator, was joined by Deputy Administrator Lori Garver where they took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  3. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr. left on stage, speaks during his first NASA Update as Deputy Administrator Lori Garver looks on at right,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  4. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr. left, speaks during his first NASA Update as Deputy Administrator Lori Garver looks on,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  5. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Deputy Administrator Lori Garver makes a point as she speaks during a NASA Update with Administrator Charles F. Bolden Jr.,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  6. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr., left on stage, speaks during his first NASA Update as Deputy Administrator Lori Garver looks on at right,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  7. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr. is seen on a television camera monitor while speaking at his first NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator, was joined by Deputy Administrator Lori Garver where they took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  8. NASA Update

    NASA Image and Video Library

    2009-07-20

    NASA Administrator Charles F. Bolden Jr., left on stage, speaks during his first NASA Update as Deputy Administrator Lori Garver looks on,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  9. NASA Update

    NASA Image and Video Library

    2009-07-20

    Alan Ladwig, senior advisor to the NASA Administator, far left, makes a point as he introduces NASA Administrator Charles F. Bolden Jr. and Deputy Administrator Lori Garver at a NASA Update,Tuesday, July 21, 2009, at NASA Headquarters in Washington. Bolden, NASA's 12th Administrator and Garver took the time to introduce themselves and outline their vision for the agency going forward. No questions were taken during the session. Photo Credit: (NASA/Bill Ingalls)

  10. [Antidote update].

    PubMed

    Kiyota, Kazuya

    2016-02-01

    In Japan, several products of the antidote for poisoning have been authorized in clinical use from some recent years. For example, Hydroxcobalamin for cyanide poisoning was introduced in 2008. In 2009, Ministry of Health, Labour and Welfare invited suggestions of demand of pharmaceutical products which is high in the need in the medical care but yet unauthorized. Japanese Society for Clinical Toxicology and Japan Poison Information Center applied some candidates including methyleneblue (MB) and fomepizole, both of them were authorized in clinical market in 2015. MB is the medicine for methemoglobinemia, caused by variety of chemical products such as nitrogen oxide. Fomepizole is the antidote for methanol and ethyleneglycol, blocking alcohol dehydrogenase.

  11. Listening to Lyrica: contested illnesses and pharmaceutical determinism.

    PubMed

    Barker, Kristin K

    2011-09-01

    Fibromyalgia syndrome is a debilitating pain disorder of unknown origins and a paradigmatic contested illness. As with other contested illnesses, the reality of fibromyalgia is disputed by many physicians. Thus, millions of individuals who are diagnosed with fibromyalgia must cope with chronic symptoms as well as medical and public skepticism. In this context, the U.S. Federal Drug Administration's approval of Lyrica, the first prescription medication specifically for the management of fibromyalgia, is of considerable interest. In this paper I examine the cultural logic whereby the existence (and marketing) of an officially approved prescription medication for a condition lends support to the biomedical existence of the condition itself. I label this logic pharmaceutical determinism and argue that it represents an important new phase in the proliferation of contested illness diagnoses. Using the case of Lyrica, I describe the role that pharmaceutical companies and pharmaceuticals themselves play in promoting and legitimating contested diagnoses and validating those who are so diagnosed. Through a narrative analysis of the Lyrica direct-to-consumer advertising campaign and the responses of fibromyalgia sufferers to the introduction and marketing of Lyrica, I demonstrate the symbiotic relationship between the interests of the pharmaceutical industry, contested illness legitimization, and medicalization. I also provide a gender analysis of this relationship, foregrounding how contested illnesses continue to be shaped by their feminization in a cultural context that equates women with irrationality. Finally, I address the consequences and limitations of relying on the pharmaceutical industry for illness validation.

  12. Pharmaceutical care and community pharmacists' understanding of bisphosphonate dosing information.

    PubMed

    Li, W W; Kendler, D L

    2004-12-01

    To evaluate pharmacists' knowledge of approved dosing information for cyclic etidronate, alendronate and risedronate in the treatment of postmenopausal osteoporosis; and to assess its relationship to demographic and pharmaceutical care factors. Fax-back questionnaire to evaluate pharmacists' knowledge of approved bisphosphonate dosing information and their involvement in pharmaceutical/patient care activities through independent indices. Community pharmacies in both urban and rural settings in British Columbia. Pharmacies surveyed with 22% response rate (163 pharmacists), 47% male and 54% owners/managers. Most were independent (31%) or volunteer chain (28%) pharmacies. Mean bisphosphonate dosing knowledge score was 76 +/- 11% (mean +/- SD). Mean scores (+/-SD) for questions pertaining to alendronate (92 +/- 13%) were higher than risedronate (81 +/- 26%) and etidronate (48 +/- 19). Pharmacists were least familiar with approved dosing instructions regarding the lack of need to remain upright after etidronate dosing, spacing out of etidronate from food/antacids/calcium/vitamins, and whether risedronate may be taken at bedtime. Factors found to affect pharmacists' bisphosphonate knowledge scores included employment in higher volume pharmacies and greater number of years in practice. Pharmacists in the upper tertile of pharmaceutical care index scores had similar bisphosphonate knowledge scores to those delivering less pharmaceutical care. Pharmacist gender, being owner/manager, and continuing education hours were not significantly associated with higher knowledge or pharmaceutical care scores. There is a wide range of knowledge of bisphosphonate dosing and delivery of pharmaceutical care amongst community pharmacists surveyed. Given the importance of proper bisphosphonate dosing to optimize drug absorption and to minimize toxicity, pharmacist education should be a priority.

  13. Occupational allergy to pharmaceutical products.

    PubMed

    Whitaker, Paul

    2016-04-01

    Occupational allergy in healthcare workers is common and can lead to significant costs from both loss of productivity within the workforce as well as those associated with diagnosis and treatment. This review aims to provide an update on drugs implicated in causing occupational allergy. Drugs traditionally reported as causing occupational allergy, such as penicillin, remain problematic. However, as their use reduces and newer drugs, such as cephalosporins, are used more frequently there is a changing pattern to occupational sensitization. In some studies up to 17% of healthcare workers now appear sensitized to cephalosporins. Other drug classes also reported include proton pump inhibitors and benzodiazepines. Interestingly, drugs such as omeprazole and tetrazepam rarely cause allergy in patients but can be very sensitizing if applied topically or inhaled. Recent studies involving pharmaceutical company employees show that this problem can no longer be considered primarily related to healthcare workers. The diagnosis of occupational allergy to drugs can be complicated and has been shown to take up to 5 years from the onset of symptoms. Ultimately, workplace avoidance remains key; however, an up to date awareness of culprit drugs and the patterns of allergy seen are key to a prompt resolution of symptoms.

  14. [Fourcroy and pharmaceutical journals].

    PubMed

    Bonnemain, Bruno

    2011-04-01

    Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

  15. Improving environmental risk assessment of human pharmaceuticals.

    PubMed

    Ågerstrand, Marlene; Berg, Cecilia; Björlenius, Berndt; Breitholtz, Magnus; Brunström, Björn; Fick, Jerker; Gunnarsson, Lina; Larsson, D G Joakim; Sumpter, John P; Tysklind, Mats; Rudén, Christina

    2015-05-05

    This paper presents 10 recommendations for improving the European Medicines Agency's guidance for environmental risk assessment of human pharmaceutical products. The recommendations are based on up-to-date, available science in combination with experiences from other chemical frameworks such as the REACH-legislation for industrial chemicals. The recommendations concern: expanding the scope of the current guideline; requirements to assess the risk for development of antibiotic resistance; jointly performed assessments; refinement of the test proposal; mixture toxicity assessments on active pharmaceutical ingredients with similar modes of action; use of all available ecotoxicity studies; mandatory reviews; increased transparency; inclusion of emission data from production; and a risk management option. We believe that implementation of our recommendations would strengthen the protection of the environment and be beneficial to society. Legislation and guidance documents need to be updated at regular intervals in order to incorporate new knowledge from the scientific community. This is particularly important for regulatory documents concerning pharmaceuticals in the environment since this is a research field that has been growing substantially in the last decades.

  16. US Pharmaceutical Innovation in an International Context

    PubMed Central

    Wang, Steven; Hebert, Paul; Carpenter, Daniel; Anderson, Gerard

    2010-01-01

    Objectives. We explored whether the United States, which does not regulate pharmaceutical prices, is responsible for the development of a disproportionate share of the new molecular entities (NMEs; a drug that does not contain an active moiety previously approved by the Food and Drug Administration) produced worldwide. Methods. We collected data on NMEs approved between 1992 and 2004 and assigned each NME to an inventor country. We examined the relation between the proportion of total NMEs developed in each country and the proportion of total prescription drug spending and gross domestic product (GDP) of each country represented. Results. The United States accounted for 42% of prescription drug spending and 40% of the total GDP among innovator countries and was responsible for the development of 43.7% of the NMEs. The United Kingdom, Switzerland, and a few other countries innovated proportionally more than their contribution to GDP or prescription drug spending, whereas Japan, South Korea, and a few other countries innovated less. Conclusions. Higher prescription drug spending in the United States does not disproportionately privilege domestic innovation, and many countries with drug price regulation were significant contributors to pharmaceutical innovation. PMID:20403883

  17. Value of pharmaceuticals: ensuring the future of research and development.

    PubMed

    Serajuddin, Hamida K; Serajuddin, Abu T M

    2006-01-01

    To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after

  18. Colloid update.

    PubMed

    Argalious, Maged Y

    2012-01-01

    This update aims to provide an evidence based review of natural and synthetic colloids with a special emphasis on the various generations of the synthetic colloid hydroxyethyl starch. The effect of 1(st), 2(nd) and 3(rd) generation hetastarches on bleeding, coagulopathy, acute kidney injury and mortality will be discussed. The results of randomised controlled trials addressing morbidity and mortality outcomes of colloid versus crystalloid resuscitation in critically ill patients will be described. In addition, the rationale and evidence behind early goal directed fluid therapy (EGDFT) including a practical approach to assessment of dynamic measures of fluid responsiveness will be presented.

  19. Pharmaceutical Education in Thailand.

    ERIC Educational Resources Information Center

    Charupatanapong, Nawarut; Rascati, Karen L.

    1991-01-01

    The pharmaceutical education system in Thailand is described and compared to that of Great Britain. The program in Thailand is a five-year curriculum with a two-year prepharmacy natural sciences program. Students start internships after the fourth year. Neither country emphasizes undergraduate preclinical experience nor requires licensing…

  20. Reflections on Pharmaceutical Education.

    ERIC Educational Resources Information Center

    Smith, Robert E.

    1992-01-01

    A discussion of the implications of adopting a new example for pharmaceutical education focuses on the need to develop a new pharmacy college culture and on the faculty's role in addressing stated educational goals. Anticipated changes in staffing and faculty development and difficulties in reorganizing curricula are examined. (MSE)

  1. The extended pharmaceutical enterprise.

    PubMed

    Cavalla, David

    2003-03-15

    The availability of widespread contractual services led to the birth of the virtual company in the 1990s. As the concept has matured, and the biotechnology sector diversified, interchange of intellectual property in the form of collaborative and license arrangements opens up still further the opportunities for outsourced forms of pharmaceutical R&D.

  2. Free trade in pharmaceuticals.

    PubMed

    Outterson, M Kevin

    2004-09-06

    Provisions in the Australia-United States Free Trade Agreement (AUSFTA) may threaten the Australian Pharmaceutical Benefits Scheme (PBS), the "gold standard" of such programs worldwide. If Australia postpones passing of the US Free Trade Agreement Implementation Bill in the Senate, there will be opportunity for broader interests in both the United States and Australia to carefully study the agreement. The provisions of AUSFTA relating to the PBS are supposed to promote transparency, but the pharmaceutical manufacturers themselves (who are demanding transparency) do not reveal the content of their submissions to the Pharmaceutical Benefits Advisory Committee, or disclose all their financial relationships with researchers and policymakers. In AUSFTA, the "public health" language of affordable prescription drugs is missing and is replaced by language supporting "pharmaceutical innovation". Debate as to whether AUSFTA will force significant changes to the PBS, including higher drug prices, is currently under way in Australia. Perhaps the appropriate target of reforms should be the excessive US drug prices, and not the economically efficient Australian drug prices.

  3. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  4. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  5. RESRAD update

    SciTech Connect

    Yu, C.; Cheng, J.J.; Zielen, A.J.; Jones, L.G.; LePoire, D.J.; Wang, Y.Y. ); Yuan, Y.C. ); Loureiro, C.O. . Escola de Engenharia); Wallo, A. III; Peterson, H. . Offic

    1993-01-01

    A microcomputer program called RESRAD, which implements a pathway analysis method for radiological risk assessment, was developed by Argonne National Laboratory (ANL) in 1989. This program is used to derive allowable residual concentrations of radionuclides in soil and to predict effective dose equivalents and excess cancer incidence risks incurred by an individual exposed to radioactive materials. Since its development, the RESRAD code has been adopted by DOE in Order 5400.5 for the derivation of soil cleanup criteria and dose calculations, and it has been used widely by DOE, other agencies, and their contractors. The original models used by ANL to develop RESRAD were initially developed as part of a DOE effort that began in the early 1980s and involved most of the national laboratories and DOE program offices. The RESRAD code is continuously improved and updated to incorporate comments from users and new features that ease the interaction with users and increase the code's capability and flexibility. The DOE Offices of Environmental Guidance and Environmental Restoration also provide periodic guidance regarding any significant changes to the code. The RESRAD update, Version 5.0, has substantial improvements in many aspects compared with the last version released in 1989.

  6. RESRAD update

    SciTech Connect

    Yu, C.; Cheng, J.J.; Zielen, A.J.; Jones, L.G.; LePoire, D.J.; Wang, Y.Y.; Yuan, Y.C.; Loureiro, C.O.; Wallo, A. III; Peterson, H.; H Williams, W.A.

    1993-05-01

    A microcomputer program called RESRAD, which implements a pathway analysis method for radiological risk assessment, was developed by Argonne National Laboratory (ANL) in 1989. This program is used to derive allowable residual concentrations of radionuclides in soil and to predict effective dose equivalents and excess cancer incidence risks incurred by an individual exposed to radioactive materials. Since its development, the RESRAD code has been adopted by DOE in Order 5400.5 for the derivation of soil cleanup criteria and dose calculations, and it has been used widely by DOE, other agencies, and their contractors. The original models used by ANL to develop RESRAD were initially developed as part of a DOE effort that began in the early 1980s and involved most of the national laboratories and DOE program offices. The RESRAD code is continuously improved and updated to incorporate comments from users and new features that ease the interaction with users and increase the code`s capability and flexibility. The DOE Offices of Environmental Guidance and Environmental Restoration also provide periodic guidance regarding any significant changes to the code. The RESRAD update, Version 5.0, has substantial improvements in many aspects compared with the last version released in 1989.

  7. Immunization update.

    PubMed

    Mirza, Ayesha; Rathore, Mobeen H

    2007-01-01

    Although the development and licensure of new vaccines over the last 2 years has generated a lot of excitement as well as debate, there is a lot more to come. Not discussed in this article. licensure of another long-awaited vaccine albeit for use in adults was that for herpes zoster. The second HPV and rotavirus vaccines are awaiting approval in the US. Next in line are the vaccines both prophylactic as well as therapeutic against HIV. Topics of debate over the new vaccines include discussions amongst practices as to the affordability and cost of the new vaccines as well as the ethical debate amongst lawmakers and the general public regarding the rights and wrongs of compulsory vaccination against HPV. Another ongoing discussion is regarding the availability of approved vaccines. Shortages have been seen with several of the childhood vaccines including heptavalent pneumococcal conjugate vaccine, tetravalent meningococcal conjugate vaccine, hepatitis A vaccine, as well as the ongoing saga with influenza vaccines. Across the globe while the struggle against polio continues, there is encouraging news regarding the reduction in measles-related deaths, particularly in Africa. The last few years have indeed been landmark years in infectious disease research as the search continues for better and safer vaccines globally.

  8. The prevalence and pattern of pharmaceutical and excipient exposure in a neonatal unit in Slovenia.

    PubMed

    Fister, Petja; Urh, Spela; Karner, Aleksandra; Krzan, Mojca; Paro-Panjan, Darja

    2015-01-01

    Because of the restraints on conducting studies on pharmaceutical use in sick newborns, many drugs are used off-label in this population. Moreover, industrially manufactured pharmaceuticals may contain different excipients, which may be either untested or not licensed for use in neonates. The aim of our study was to determine the prevalence and pattern of pharmaceutical and excipient exposure in newborns hospitalized at the Department of Neonatology, Ljubljana, Slovenia. A longitudinal prospective cross-sectional study was performed during a one-month period and included all hospitalized neonates. Route of administration, site of action, type of manufacture, licensing status, type and concentrations of excipients for all pharmaceuticals given to the neonates were determined. Twenty seven different pharmaceutical preparations were prescribed to a total of 48 hospitalized newborns. In most cases, newborns were prescribed various pharmaceuticals that were not approved for use in this population. Newborns were exposed to 60 different excipients in industrially manufactured pharmaceutical preparations. More than half of the received pharmaceuticals contained potentially harmful and harmful excipients. Two-thirds of pharmaceutical preparations for neonates were used off-label. Newborns receive more auxiliary substances, which may be unsuitable for this age group and may even be toxic to them, via industrially manufactured pharmaceuticals.

  9. EU pharmaceutical expenditure forecast

    PubMed Central

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and Objectives With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Method In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012–2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. Results According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (−€9,367 million), France

  10. Document Update and Compare

    NASA Technical Reports Server (NTRS)

    Knoch, C. F.; Caldwell, D. C.; Caldwell, D. L.

    1983-01-01

    Document Update and Compare programs provide simple computerized documentmaintenance system on Data General NOVA 840 computer. Document Update program allows user to update document either by batch or terminal input. Documents are modified and lists of modifications printed out.

  11. Exploration Update

    NASA Technical Reports Server (NTRS)

    2006-01-01

    Delores Beasley, NASA Public Affairs, introduces the panel who consist of: Scott "Doc" Horowitz, Associate Administrator of Exploration Systems from NASA Headquarters; Jeff Henley, Constellation Program Manager from NASA Johnson Space Flight Center; and Steve Cook, Manager Exploration Launch Office at NASA Marshall Space Flight Center. Scott Horowitz presents a short video entitled, "Ares Launching the Future". He further explains how NASA personnel came up with the name of Ares and where the name Ares was derived. Jeff Henley, updates the Constellation program and Steve Cook presents two slide presentations detailing the Ares l crew launch vehicle and Ares 5 cargo launch vehicle. A short question and answer period from the news media follows.

  12. Pharmaceutical risk-sharing agreements.

    PubMed

    Cook, Joseph P; Vernon, John A; Manning, Richard

    2008-01-01

    Increased spending on pharmaceuticals continues to foster debate over healthcare policy. The increasing costs of bringing products to the market, as well as increased utilization of pharmaceuticals contribute to increased pharmaceutical expenditure; however, appropriate pharmaceutical use can, in certain cases, reduce overall healthcare costs. Nevertheless, the perception of high drug prices still puts pressure on pharmaceutical companies to build confidence in the proposition that their products are worth the additional expense. One potential approach to building this confidence, and maintaining investment incentives, is for the pharmaceutical company to share the risk of a situation in which there is uncertainty about whether the product is effective for the consumer and payer. Such risk-sharing arrangements for pharmaceuticals, like warranties, can be used to signal high quality when product quality is not fully observable. While there may be difficulties in devising such schemes for every product, such risk-sharing plans may become a staple feature of the market in the future.

  13. Gray marketing of pharmaceuticals.

    PubMed

    Chaudhry, P E; Walsh, M G

    1995-01-01

    Pharmaceutical marketers in the European Union are constrained by regulated prices, opening up opportunities for gray marketers. The authors investigate the legal framework that regulates gray markets by summarizing and analyzing relevant European Court of Justice decisions that favor gray marketers and actually foster parallel trade. Before marketing managers can develop effective strategies in this marketplace, they must first understand the precedents of the legal system in which they will be operating.

  14. Wastage of pharmaceuticals.

    PubMed

    Hart, R J; Marshall, F S

    1976-12-04

    Wastage of pharmaceuticals was studied for three months at a 520-bed hospital in Suffolk. Drugs worth 1104 pounds were brought to the pharmacy for destruction. Only 40 pounds worth could be put back into stock. It is suggested that the use of blister-packing together with conservative prescribing, supply, and suitable storage of medicines could lead to important savings of drugs discarded each year in English hospitals, which from this study were estimated to cost in excess of 1 million pounds.

  15. Generic drug approval: a US perspective.

    PubMed

    Nagori, B P; Mathur, V; Garg, S

    2011-03-01

    Generic drugs are identical or bioequivalent versions of the brand name drugs. They are the economic alternative of the costlier brand name drugs. This article presents a general overview of the procedure and regulatory aspects relating to generic drug approval in the US. A computerized search was conducted to find literature on generic drug approval in the US. The literature was searched using the following key words: generic drug, brand name drug, Hatch-Waxman Act, Medicare Act, NDA, ANDA, CTD and exclusivity. The search results were filtered for the literature describing and analyzing the procedure and regulatory provisions for generic drug approval in the US. After the screening total 19 applicable literature remained. In the US standardized procedures for the recognition of generic drugs have been laid down under the Drug Price Competition and Patent Term Restoration Act, 1984 (the Hatch-Waxman Act). Provisions of this Act such as patent challenge, patent term extension and data exclusivity have created profound effects on the approval, sale and distribution of the pharmaceuticals in the US. The Hatch-Waxman Act is an excellent piece of legislation that takes care of the rights of both the brand name and generic drug companies. This article presents only an overview of generic drug approvals and for all practical purposes official resources should be referred.

  16. Ebola Update.

    PubMed

    O'Keefe, Louise C

    2016-01-01

    The Ebola virus disease first appeared in 1976 in the Sudan and the Democratic Republic of Congo. The most recent outbreak occurred in West Africa in March 2014 and quickly spread in surrounding countries. Ebola spreads through direct contact with the body fluids of an infected individual. The incubation period for Ebola is 2 to 21 days. Individuals are infectious when symptomatic. Identifying individuals at high risk for Ebola in the United States includes early recognition of symptoms and a history of travel to an Ebola-affected area. Multiple diagnostic tests exist and should include a complete blood count and a comprehensive metabolic profile. Standard, contact, and droplet precautions are advised when taking care of patients with Ebola. Appropriate personal protective equipment as recommended by the Centers for Disease Control and Prevention should be worn. No vaccine or antiviral drug has been approved, but vaccine trials are under way. Occupational health nurses play a key role in educating employees about this disease.

  17. Redfield Energy Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  18. Pharmaceutical product development: A quality by design approach

    PubMed Central

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  19. Pharmaceutical product development: A quality by design approach.

    PubMed

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  20. [Questions about pharmaceutical expertise].

    PubMed

    Sauer, Fernand

    2012-01-01

    Over the last thirty years, many areas of expertise have developed in the pharmaceutical industry, from research and production to delivery to the patient. Strict European regulations and international best practice guidelines have shaped the expertise of pharmaceutical firms. Governments have set up health agencies to strengthen the supervision of private operators by recruiting in-house scientific experts and expert committees. The private and public sectors compete to recruit the best experts, and conflicts of interest must be addressed. The recent 'Mediator' (Benfluorex) case in France raises many questions about the potential failures of the health security system. Beyond the primary responsibility of the company, the main concern is off-label use. An effort to strengthen the legal framework and the tools used to collect, analyze and publicize pharmacovigilance data is currently underway at a national and European level. The competent authorities must restore public confidence through a more diligent and transparent handling of sensitive issues related to high-risk medicine. In a country where drug consumption is particularly high, doctors and pharmaceutical experts have been accused of becoming accustomed to risk and of loosing sight of the benefit to the patient. Health professionals in the private and public sectors must regain the appropriate health security reflexes to promote a more rational use of drugs.

  1. Trade, TRIPS, and pharmaceuticals.

    PubMed

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.

  2. 78 FR 38423 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ..., and institutional communications. Current definitions of ``sales literature,'' ``advertisement,'' and... period.'' The Exchange also proposed to update the definition of ``correspondence'' to ``any written...), ``Approval by Registered Options Principal'', to replace the phrase ``advertisements, sales literature, and...

  3. 78 FR 76389 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ...--design. Master plan update completion/airport geographic information system. Brief Description of Project... Federal Aviation Administration Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals...). Construction of snow removal equipment building (geothermal heat system). Hangar taxi lane improvements. Hangar...

  4. Update in Diffuse Parenchymal Lung Disease 2013

    PubMed Central

    Kaminski, Naftali

    2015-01-01

    The period covered by this update can be considered as the most exciting period in idiopathic pulmonary fibrosis (IPF) research. It started with the identification of genetic variants that are associated with IPF in the majority of patients and continued with discovery of molecular and genetic biomarkers that predict distinct clinical presentations of patients with IPF and potential new biological mechanisms. More importantly, the period ends with the publication of two groundbreaking studies that confirmed that two drugs, pirfenidone and nintedanib, slowed disease progression, leading to a historic approval by the FDA. In this update, we describe these key advances, their scientific and significant clinical implications, and future directions. PMID:25635490

  5. WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

    PubMed

    2006-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.

  6. Drilling update

    NASA Astrophysics Data System (ADS)

    Richman, Barbara T.

    At its March 31 meeting the governing board of the Joint Oceanographic Institutions, Inc. (JOI), designated Texas A&M University to direct scientific operations for the new phase of scientific ocean drilling. William Merrell, associate dean of geosciences at Texas A&M, is leading an interim planning team in implementing the recommendations of the National Science Foundation's (NSF) Ad Hoc Advisory Group on Crustal Studies (Eos, February 22, 1983, p. 73). The ad hoc group, chaired by Charles Drake, recommended that scientific ocean drilling be pursued not with the Glomar Challenger or the Glomar Explorer, but with one of the roughly half-dozen commercial drilling ships that have become available with the slackening of the commercial drilling market.Foremost of the tasks facing the interim planning team is to write a request for proposals (RFP) for a drill ship and to define performance criteria for a commercial drilling platform. The RFP is expected to be issued by Texas A&M in 6-8 weeks, according to Philip Rabinowitz, acting project director and a professor in the university's oceanography department. Once those tasks are completed and a successful bidder is found, a formal proposal will be made to NSF through JOI. The proposal will be subject to the usual NSF peer review process. If the proposal is approved, Rabinowitz said that Texas A&M would expect actual drilling to begin in October 1984. In addition to Merrell and Rabinowitz, the interim planning team also includes acting chief scientist Stefan Gartner.

  7. "Insuring" the continued solvency of pharmaceutical companies in the face of product liability class actions.

    PubMed

    Chodock, Rochelle; Yolkut, David; Connolly, Dennis R

    2005-01-01

    Costly product liability lawsuits continue to plague the pharmaceutical industry, and insurance to cover these losses is severely inadequate. Furthermore, questionable regulation of drugs exists once a pharmaceutical has passed FDA approval. This article describes a plan that uses a capitalistic, rather than a governmental, approach to solve both the insurance and the quality control problems. Although the proposed plan has never been used to insure pharmaceutical companies, different permutations of it have been used to insure other litigation-prone industries. Success from the proposed insurance entity results from the combined knowledge of scientists and actuaries to provide both protection from product liability lawsuits for the pharmaceutical industry and enhanced post-market surveillance of pharmaceuticals.

  8. Is the United States Still Dominant in the Global Pharmaceutical Innovation Network?

    PubMed Central

    Hu, Yuanjia; Scherngell, Thomas; Man, Si Nga; Wang, Yitao

    2013-01-01

    The dramatic growth of research and development activities in the pharmaceutical sector in emerging economies raises the question of whether the United States still keeps its dominant role in the global pharmaceutical innovation landscape. This paper focuses on investigating the role of the United States in global pharmaceutical innovation, and differs from previous studies by shifting attention to a network analytic perspective to track the global distribution of pharmaceutical inventions. Our sample is composed of key patents covering all new drugs approved by the Food and Drug Administration between 1996 and 2010. The results show that the United States still dominates in the global pharmaceutical innovation network, especially when it comes to essential core inventions. However, the United States shows a slightly decreasing prominence in the networks of either total new drugs or New Molecular Entity (NME) drugs in the time period 2006–2010 as compared to previous time periods, revealed by subtle traces of network centralities. PMID:24223710

  9. Is the United States still dominant in the global pharmaceutical innovation network?

    PubMed

    Hu, Yuanjia; Scherngell, Thomas; Man, Si Nga; Wang, Yitao

    2013-01-01

    The dramatic growth of research and development activities in the pharmaceutical sector in emerging economies raises the question of whether the United States still keeps its dominant role in the global pharmaceutical innovation landscape. This paper focuses on investigating the role of the United States in global pharmaceutical innovation, and differs from previous studies by shifting attention to a network analytic perspective to track the global distribution of pharmaceutical inventions. Our sample is composed of key patents covering all new drugs approved by the Food and Drug Administration between 1996 and 2010. The results show that the United States still dominates in the global pharmaceutical innovation network, especially when it comes to essential core inventions. However, the United States shows a slightly decreasing prominence in the networks of either total new drugs or New Molecular Entity (NME) drugs in the time period 2006-2010 as compared to previous time periods, revealed by subtle traces of network centralities.

  10. Bolaamphiphiles: A Pharmaceutical Review

    PubMed Central

    Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.

    2014-01-01

    The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179

  11. Price competition in the Chinese pharmaceutical market.

    PubMed

    Wang, Y Richard

    2006-06-01

    We study price competition between high-quality global products and low-quality local products in a developing country, i.e., China, Nearly all previous studies on pharmaceutical price competition focused on developed countries with bioequivalent generics. In China, local generic products are not bioequivalent and are deemed of lower quality, while global products in the same class are considered similar in quality and better substitutes. We hypothesize that local generic competition drives down local product price but not global product price. In addition, we hypothesize that therapeutic competition among similar global products lowers global product price. Our empirical results support both hypotheses. Number of local generic competitors has a significantly negative effect on local product price but no effect on global product price, while number of global therapeutic competitors has a significantly negative effect on global product price. Policy changes that encourage bioequivalent local products and accelerate global product approvals will enhance price competition in China.

  12. Prospects for Anti-Biofilm Pharmaceuticals

    PubMed Central

    Stewart, Philip S.

    2015-01-01

    This commentary highlights several avenues currently being pursued in research labs to the development of new anti-biofilm pharmaceuticals. There is a real need for alternative therapeutic modalities for treating the persistent infections that sometimes form on implanted medical devices or compromised niches within the body. Strategies being researched include discovering new antimicrobial agents that kill microorganisms in biofilms more effectively than do existing antibiotics, designing drugs that block microbial adhesion or interfere with intercellular communication, developing chemistries to disperse biofilms, and combining agents with different mechanisms of action. Though the need is great, the pathway to commercialization of new drugs is steep. One possible streamlined approach to navigating the regulatory approval process is to repurpose old drugs, a strategy that a few groups have shown can yield agents with anti-biofilm properties. PMID:26343685

  13. Automatic conceptual indexing of French pharmaceutical theses.

    PubMed

    Mary, Vincent; Pouliquen, Bruno; Le Duff, Franck; Darmoni, Stefan J; Segui, Alain; Le Beux, Pierre

    2002-01-01

    French pharmaceutical theses are rarely quoted. If the main obstacles originate from language or access barriers, proper indexation could also be blamed. Manually extracted key-words don't necessary come from a structured thesaurus. In the following work, this manual indexing method is compared to an automated one, "Nomindex", based on UMLS. The automated method is improved by the addition of a relevance scoring system. The first indexing step consists of downloading, adapting and indexing theses in electronic format. Results will then be analyzed and sorted by relevance, through the comparison of classic statistical indices (noise, silence and relevance). It was assumed that the manually obtained key-words were always relevant. The silence of manual indexing is nevertheless high: seven new key-words are proposed by Nomindex, which results are mixed (10% of silence, but 50% of noise). These results are promising on the first experiment on pharmaceutical document without lexicon improvement. The indexing, if it is currently insufficient for a real life use, could easily be improved by specific updates of the lexicon.

  14. 76 FR 4578 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Adoption of the Revised...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-26

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Virginia; Adoption of the Revised Lead Standards and Related Reference Conditions, and Update of Appendices AGENCY... conditions, and update the list of appendices under ``Documents Incorporated by Reference.'' In the Final...

  15. 76 FR 14805 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Adoption of the Revised...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-18

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Virginia; Adoption of the Revised Lead Standards and Related Reference Conditions and Update of Appendices; Withdrawal... lead standards of 0.15 micrograms per cubic meter ( g/m3), related reference conditions, and update the...

  16. FDA-approved small-molecule kinase inhibitors.

    PubMed

    Wu, Peng; Nielsen, Thomas E; Clausen, Mads H

    2015-07-01

    Kinases have emerged as one of the most intensively pursued targets in current pharmacological research, especially for cancer, due to their critical roles in cellular signaling. To date, the US FDA has approved 28 small-molecule kinase inhibitors, half of which were approved in the past 3 years. While the clinical data of these approved molecules are widely presented and structure-activity relationship (SAR) has been reported for individual molecules, an updated review that analyzes all approved molecules and summarizes current achievements and trends in the field has yet to be found. Here we present all approved small-molecule kinase inhibitors with an emphasis on binding mechanism and structural features, summarize current challenges, and discuss future directions in this field.

  17. The Pharmaceutical Commons

    PubMed Central

    Lezaun, Javier

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. PMID:25866425

  18. Deliquescence of pharmaceutical systems.

    PubMed

    Mauer, Lisa J; Taylor, Lynne S

    2010-12-01

    Deliquescence is a first order phase transition from solid to solution that occurs at a relative humidity (RH) that is characteristic to the crystalline compound. Such dissolution of active pharmaceutical ingredients and excipients can lead to detrimental physical and chemical instabilities. Furthermore, in systems containing more than one deliquescent component, the RH of the solid-solution transition will be lowered, leading to some level of dissolution at unexpectedly low RH conditions. Deliquescence lowering is independent of the ratio of the deliquescent components and therefore is of concern for any formulation containing two or more deliquescent compounds. Because chemical reactions occur much more readily in solution, deliquescence will enhance the degradation of labile APIs. RH fluctuations will lead to cycles of deliquescence and efflorescence (crystallization), which will contribute to particle agglomeration and caking. This review will address the phenomenon of deliquescence, the significance of deliquescence to pharmaceutical systems, measurement techniques, the kinetics and thermodynamics of deliquescence, the behavior of mixtures of deliquescent compounds (including phase diagrams and thermodynamics of binary systems), and consequences of deliquescence on chemical and physical stability.

  19. Pharmaceutical Education and the Translation of Pharmaceutical Care into Practice.

    ERIC Educational Resources Information Center

    Newton, Gail D.

    1991-01-01

    A systematic approach to reform of pharmaceutical education is seen as necessary to link intended outcomes of reform to a progressive and generally accepted mission of professional practice. Cooperation between pharmaceutical education, professional organizations, and regulatory agencies is viewed as necessary and refinement of professional…

  20. Pharmaceutical Education and the Translation of Pharmaceutical Care into Practice.

    ERIC Educational Resources Information Center

    Newton, Gail D.

    1991-01-01

    A systematic approach to reform of pharmaceutical education is seen as necessary to link intended outcomes of reform to a progressive and generally accepted mission of professional practice. Cooperation between pharmaceutical education, professional organizations, and regulatory agencies is viewed as necessary and refinement of professional…

  1. 7 CFR 274.1 - Issuance system approval standards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... set forth under § 277.18(f) of this chapter. (f) Advance planning documentation. State agencies must... submission of advance planning documents (APDs). (1) Pilot project approval requirements. To the extent the... simultaneously with pilot operations. Submission of an Advanced Planning Document Update to request FNS...

  2. 7 CFR 274.1 - Issuance system approval standards.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... set forth under § 277.18(f) of this chapter. (f) Advance planning documentation. State agencies must... submission of advance planning documents (APDs). (1) Pilot project approval requirements. To the extent the... simultaneously with pilot operations. Submission of an Advanced Planning Document Update to request FNS...

  3. EPA Approves Massachusetts Plan to Protect Cape Cod Waters

    EPA Pesticide Factsheets

    EPA has formally approved an updated plan from the Commonwealth of MA that creates a robust framework for Cape Cod communities to reduce nitrogen levels that are currently harming ecological health of ponds, bays and other surface waters on the Cape.

  4. 7 CFR 274.1 - Issuance system approval standards.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... set forth under § 277.18(f) of this chapter. (f) Advance planning documentation. State agencies must... submission of advance planning documents (APDs). (1) Pilot project approval requirements. To the extent the... simultaneously with pilot operations. Submission of an Advanced Planning Document Update to request FNS...

  5. 77 FR 66945 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably Available Control Technology Update To Address Control Techniques Guidelines Issued in 2006, 2007... proposing to approve a State Implementation Plan (SIP) revision submitted by the State of New Hampshire. The...

  6. 77 FR 66921 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably Available Control Technology Update To Address Control Techniques Guidelines Issued in 2006, 2007... approving a State Implementation Plan (SIP) revision submitted by the State of New Hampshire. The revision...

  7. 76 FR 34091 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street, SW., Washington,...

  8. 75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of... Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; e-mail...

  9. 78 FR 52893 - Approval and Promulgation of Implementation Plans; State of Iowa

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; State of Iowa AGENCY... the State Implementation Plan (SIP) for the state of Iowa. The purpose of these revisions is to update... Iowa statewide rules previously approved by EPA and will ensure consistency between the...

  10. 77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Washington,...

  11. 78 FR 30770 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Illinois; Air... National Ambient Air Quality Standards (NAAQS) for ozone and particulate matter (PM). EPA is approving a... Implementation Plan at 35 Illinois Administrative Code part 243, which updates National Ambient Air...

  12. Updating the Magnitudes of the Planets in The Astronomical Almanac

    DTIC Science & Technology

    2003-01-01

    USNO/AA Technical Note 2003-04 Updating the Magnitudes of the Planets in The Astronomical Almanac James L. Hilton The content of this Tech...the magnitudes of Mercury and Venus used in the AsA 2005 and 2006. Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden...SUBTITLE Updating The Magnitudes Of The Planets In The Astronomical Almanac 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

  13. [Operation Pangea - standing together in combat against international pharmaceutical crime].

    PubMed

    Smolka, Kirstin; Gronwald, Klaus

    2017-09-19

    Crime on the internet has grown accordingly to the increased use of the internet in everyday life. This includes illegal trading of pharmaceuticals via the internet. Trading in pharmaceuticals as "special commodities" underlies certain legal regulations in Germany, as in most other countries worldwide.Mail order trade (colloquially also known as internet trade) in pharmaceuticals requires approval of the competent regulatory authority. However, numerous illegal internet vendors of medicines present their websites to customers, purporting to be legal pharmacies and trading good and genuine medicines.It is not always easy for customers or patients to distinguish between legal websites, i. e. pharmacies operating with the approval of the authorities, and illegal, criminal websites. Patients accept dangerous risks when they order medicines on such illegal websites. Consumption of falsified or unlicensed pharmaceuticals of unknown origin often exposes patients' health to serious risks and dangers.Operation PANGEA is now in its tenth year of fighting illegal internet trade in pharmaceuticals at an internationally coordinated level. The results of Operation PANGEA are published in national and international media. Thus the public should be alert to the risks of buying medicines from one of the numerous illegal vendors on the internet.The competence for combatting illegal sales of medicines lies with customs and police agencies amongst others. These enforcement agencies regularly participate in the annual PANGEA Operations. The following article describes the origin and background of this operation, and outlines both the work of customs and police in this context, as well as the results of the latest PANGEA Operation.

  14. Radium-223 Therapy for Patients with Metastatic Castrate-Resistant Prostate Cancer: An Update on Literature with Case Presentation

    PubMed Central

    Appleman, Leonard J.; Mountz, James M.

    2016-01-01

    Background and Purpose. Radium-223 dichloride (Xofigo®, Bayer HealthCare Pharmaceuticals Inc.) is the first α-particle emitter therapeutic agent approved by the FDA, with benefits in overall survival and delay in symptomatic skeletal event for patients with metastatic castrate-resistant prostate cancer (CRPC). Recent post hoc analyses of the phase III ALSYMPCA trial support the previously established safety profile as well as therapeutic effect and clinical outcome of Radium-223. Currently, Radium-223 is approved as a single agent therapy for metastatic CRPC. Clinical trials are currently investigating Radium-223 in additional clinical settings such as earlier asymptomatic disease and in combination with other agents including hormonal therapeutic agents and immunotherapeutic as well as chemotherapeutic agents. Trials are also ongoing in patients with other primary cancers such as breast cancer, thyroid cancer, and renal cancer metastatic to bone. In this article, the physics and radiobiology, as well as a literature update on the use of Radium-223, are provided along with case presentations, aiming at a better appreciation of research data as well as the assimilation of research data into clinical practice. PMID:27774318

  15. Radium-223 Therapy for Patients with Metastatic Castrate-Resistant Prostate Cancer: An Update on Literature with Case Presentation.

    PubMed

    Nguyen, Nghi C; Shah, Muhammad; Appleman, Leonard J; Parikh, Rahul; Mountz, James M

    2016-01-01

    Background and Purpose. Radium-223 dichloride (Xofigo®, Bayer HealthCare Pharmaceuticals Inc.) is the first α-particle emitter therapeutic agent approved by the FDA, with benefits in overall survival and delay in symptomatic skeletal event for patients with metastatic castrate-resistant prostate cancer (CRPC). Recent post hoc analyses of the phase III ALSYMPCA trial support the previously established safety profile as well as therapeutic effect and clinical outcome of Radium-223. Currently, Radium-223 is approved as a single agent therapy for metastatic CRPC. Clinical trials are currently investigating Radium-223 in additional clinical settings such as earlier asymptomatic disease and in combination with other agents including hormonal therapeutic agents and immunotherapeutic as well as chemotherapeutic agents. Trials are also ongoing in patients with other primary cancers such as breast cancer, thyroid cancer, and renal cancer metastatic to bone. In this article, the physics and radiobiology, as well as a literature update on the use of Radium-223, are provided along with case presentations, aiming at a better appreciation of research data as well as the assimilation of research data into clinical practice.

  16. To Your Health: NLM update transcript - First gene therapy cancer treatment

    MedlinePlus

    ... html To Your Health: NLM update Transcript First gene therapy cancer treatment : 09/11/2017 To use ... to follow up on weekly topics. The first gene therapy treatment for cancer recently was approved by ...

  17. More New Medication Approvals.

    PubMed

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures.

  18. Trelagliptin: First Global Approval.

    PubMed

    McKeage, Kate

    2015-07-01

    Trelagliptin (Zafatek(®)) is an orally active dipeptidyl peptidase (DPP)-4 inhibitor developed by Takeda and approved in Japan for the treatment of type 2 diabetes mellitus (T2DM). Unlike other approved agents of its class, which are usually administered once daily, trelagliptin can be administered once weekly. Phase II development of trelagliptin was discontinued in the USA and EU, as Takeda considered that the costs associated with obtaining approval in these markets were prohibitive. This article summarizes the milestones in the development of trelagliptin leading to this first approval for T2DM.

  19. Designing a Pharmaceutical Care Curriculum.

    ERIC Educational Resources Information Center

    Perrier, Donald G.; And Others

    1995-01-01

    Guidelines for developing a pharmacy school curriculum based on the principle of pharmaceutical care and professional responsibility are offered, beginning with mission statements for profession, practice, and pharmaceutical education in general. The University of Toronto experience in designing such a curriculum is chronicled as an illustration…

  20. Naming, labeling, and packaging of pharmaceuticals.

    PubMed

    Kenagy, J W; Stein, G C

    2001-11-01

    The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

  1. Pharmaceutical counseling: Between evidence-based medicine and profits.

    PubMed

    Egorova, S N; Akhmetova, T

    2015-01-01

    The number of pharmacies, which produce drug formulations locally, has recently considerably reduced in Russia. Pharmacies mainly operate as retailers of industrially manufactured drugs.Pharmaceutical consultation of customers at pharmacies aimed at responsible self-medication is the most popular and accessible feature of pharmaceutical care. In Russia there is a significant list of medicines approved for sale in pharmacies on a non-prescription basis that is specified in the product label. In this regard, the role of pharmacists in public health in Russia increases. Pharmacist, working directly with population, is an important figure for the rational use of medicines. This type of work requires high level of professional training and appropriate ethics. To explore the current status of pharmaceutical counseling in Russia. Situation analysis, surveys of pharmacists. Our experience in the system of postgraduate professional education, the results of the survey of pharmacists, and the long-term dialogue with pharmacists allowed us to identify several unresolved issues in the work of a pharmacist selling non-prescription drugs.Lack of differentiation in the functions of a pharmacist with a higher education and pharmaceutical technologist: In production/industrial pharmacy technicians are engaged in manufacturing of pharmaceutical formulations. However, due to the loss of production functions technologists had to move away from production laboratories of apothecaries to the sales area. Currently, the apothecary's assignment to receive prescriptions and dispense medications can be fulfilled by either a pharmacist or a pharmaceutical technician. It significantly discerns the pharmacy from the medical organization with clearly delineated functions of doctors and nurses. Russian regulations should consider the level of education required for high-quality pharmaceutical counseling.Contradiction between the pharmacist's special functions and trade procedure with the lack of

  2. Pharmaceutical study of Yashadabhasma.

    PubMed

    Bhojashettar, Santhosh; Jadar, P G; Rao, V Nageswara

    2012-01-01

    Rasashastra is a branch which deals with the pharmaceutics of Rasaoushadhis. Bhasmas are one among such Rasaoushadhis which are known for their low doses and fast action. A verse from Rasaratnasamuchchaya says that the bhasma prepared by using Mercury as media is of best quality. Following this principle, Yashadabhasma (Zinc calx) was prepared by subjecting it to Samanya shodhana (general purification method for all metals), Vishesha shodhana (specific putification method for Zinc), Jarana (roasting) and Marana (incineration) with Parada(Mercury) as a media under Gajaputa (classical heating system with 1000 cowdung cakes). Yellow colored Yashadabhasma which passed all the classical bhasmaparikshas (tests for properly prepared calx) was obtained after two putas. The bhasma did not pass Nishchandratva(free from shining particles) test after 1(st)puta but was passed after giving it 2(nd)puta.

  3. Pharmaceutical market access in emerging markets: concepts, components, and future.

    PubMed

    Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

    2014-01-01

    This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

  4. Pharmaceutical market access in emerging markets: concepts, components, and future

    PubMed Central

    Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

    2014-01-01

    This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities. PMID:27226834

  5. [Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

    PubMed

    Dzhalilova, K I

    2009-11-01

    Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.

  6. An Inventory and Safety Stock Analysis of Air Force Medical Service Pharmaceuticals

    DTIC Science & Technology

    2015-03-26

    An Inventory and Safety Stock Analysis of Air Force Medical Service Pharmaceuticals THESIS Blake...Department of Defense, or the United States Government. AFIT-ENS-MS-15-M-133 An Inventory and Safety Stock Analysis of Air Force Medical...APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED. AFIT-ENS-MS-15-M-133 AN INVENTORY AND SAFETY STOCK ANALYSIS OF AIR FORCE MEDICAL

  7. Methuselah's medicine: pharmaceutical innovation and mortality in the United States, 1960-2000.

    PubMed

    Schnittker, Jason; Karandinos, George

    2010-04-01

    Although there is a good deal of speculation surrounding the role of pharmaceutical innovation in late 20th century mortality improvements in the United States, there is little empirical evidence on the topic and there remains a good deal of doubt regarding whether pharmaceuticals matter at all for mortality. Using a reliable indicator of pharmaceutical innovation-yearly approvals of new molecular entities (NMEs) by the Food and Drug Administration, along with information on priority status and disease-category indication-this study examines the relationship between pharmaceutical innovation and life expectancy between 1960 and 2000. The study demonstrates a significant relationship between pharmaceutical innovation and life expectancy at birth, which is robust to controls for gross domestic product, as well as controls for various forms of medical spending. The relationship with life expectancy is robust, in part, because pharmaceutical innovation has a stronger relationship with early-life mortality (between 20 and 50) than with later-life mortality (65 and over), even though older persons consume more pharmaceuticals and many recently approved drugs target conditions more common in later life. There is, to be sure, another side to the results. There is some evidence, for example, that the relationship between pharmaceutical innovation and mortality has declined over time, suggesting a change in the kind of innovations now entering the market. Nevertheless, there is more to contemporary pharmaceutical innovation than the development of mere "halfway" technologies. The overall relationship between innovation and mortality is sufficiently strong to warrant further consideration as a key determinant of trends in mortality.

  8. Venetoclax Approved for CLL.

    PubMed

    2016-06-01

    Venetoclax, a BCL2 inhibitor, has been approved for patients with chronic lymphocytic leukemia (CLL) who lack part of chromosome 17. The FDA also approved a companion diagnostic, the Vysis CLL FISH probe kit, to detect the 17p deletion in patients' peripheral blood.

  9. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    SciTech Connect

    Lawrence, B.

    1999-04-20

    The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions. Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.

  10. Savannah River Site approved site treatment plan, 2000 annual update

    SciTech Connect

    Lawrence, B.

    2000-04-20

    The Compliance Plan Volume (Volume 1) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions. Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume 2) and is provided for information.

  11. Sex, gender, and pharmaceutical politics: From drug development to marketing.

    PubMed

    Fisher, Jill A; Ronald, Lorna M

    2010-08-01

    Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and

  12. Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia.

    PubMed

    Othman, Noordin; Vitry, Agnes I; Roughead, Elizabeth E; Ismail, Shaiful B; Omar, Khairani

    2010-11-30

    Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications, precautions for use, drug

  13. Higher Priced Older Pharmaceuticals: How Should We Respond?

    PubMed

    Irwin, Richard S; Manaker, Scott; Metersky, Mark L; Baughman, Robert P; Otulana, Tunde; Weinberger, Steven E; Sussman, Andrew J; McGrath, Norine A

    2017-10-07

    We and our patients have been aware of the high cost of medications in the United States for decades. However, we are recently witnessing a relatively new phenomenon: exponential price increases for some older pharmaceuticals that have been available for years. To assist practitioners in how to respond to the issue of higher priced pharmaceuticals, an interprofessional session was developed and held at CHEST 2016 in Los Angeles. The session proceedings and a few updates are presented here to summarize what pulmonologists, a sarcoidosis expert, a retired executive of a medical society, pharmaceutical company, pharmacy, and an ethicist advise that we do about the problem. Because the comments presented at the session and in this manuscript represent the opinions of each of the authors, this commentary in essence is an compilation of 9 editorials. It does not represent a comprehensive discussion of the field of pricing of drugs. In reflecting upon the answers to the questions posed, and regardless of their sector of healthcare, all participants stated that they focused on the patient. However, actually providing patient-focused care (i.e., the care defined from the patient's perspective) is another matter. In order to significantly improve patient satisfaction and health care outcomes, patient-focused care needs to embody the 3 Cs of 1) communication, 2) continuity of care, and 3) concordance of expectations (i.e., finding the common ground). Therefore, we discuss how the 3 Cs apply to responses to higher priced pharmaceuticals. Copyright © 2017. Published by Elsevier Inc.

  14. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

    Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

    2015-12-01

    Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter <232> and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.

  15. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  16. Updating Situation Models

    ERIC Educational Resources Information Center

    Zwaan, Rolf A.; Madden, Carol J.

    2004-01-01

    The authors examined how situation models are updated during text comprehension. If comprehenders keep track of the evolving situation, they should update their models such that the most current information, the here and now, is more available than outdated information. Contrary to this updating hypothesis, E. J. O'Brien, M. L. Rizzella, J. E.…

  17. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  18. GMK (Progenics Pharmaceuticals).

    PubMed

    Knutson, Keith L

    2002-01-01

    Progenics Pharmaceuticals is developing GMK vaccine (a ganglioside conjugate vaccine coupled to keyhole limpet hemocyanin and formulated with the adjuvant QS-21), licensed from the Memorial Sloan-Kettering Cancer Center, for the potential treatment of melanoma and other cancers [194258], [325284]. It was previously under co-development with Bristol-Myers Squibb, but in May 2001, all rights to the GMK vaccine were returned to Progenics [409168]. It was the first of a new class of ganglioside conjugate vaccine evaluated by Progenics [194258]. GMK vaccination induces antibodies against GM2 ganglioside capable of specifically killing melanoma cells. Melanoma patients with antibodies against GM2 ganglioside have significantly improved disease-free and overall survival compared to antibody-negative subjects. The vaccine is undergoing two phase III trials, the first comparing GMK to high-dose IFNalpha in melanoma patients with more serious disease and at a high risk of relapse, and the second, in collaboration with the European Organization for Research and Treatment of Cancer, comparing GMK (14 doses of GMK over three years) to no treatment other than close monitoring of malignant melanoma patients at immediate risk of relapse [409168]. In February 1999, Lehman Brothers predicted that the vaccine had a 50% probability of reaching market, with an estimated first launch date in 2002. The analysts predicted potential peak sales in 2008 of $150 million in the US and $100 million in the rest of the world at that time [319225]. In January 2000, Lehman Brothers expected that an NDA filing would take place in 2002, with possible launch of the vaccine in 2003. In addition, Lehman Brothers estimated potential peak sales at $500 million [357788]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of GMK and PRO-542 in 2002 [390063]. In July 2001, Ladenburg Thalmann predicted a $257 million

  19. Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

    PubMed

    Batt, Sharon

    2016-07-01

    A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative.

  20. Commercial aspects of pharmaceutical protein production in plants.

    PubMed

    Fischer, Rainer; Schillberg, Stefan; Buyel, Johannes F; Twyman, Richard M

    2013-01-01

    Many different plant-based systems have been used to produce recombinant pharmaceutical proteins but only a small number have made the leap from an experimental platform to a viable commercial process. This reflects a combination of factors, principally the technical issues that must be addressed to achieve competitive performance, the economic principles that need to be satisfied to ensure manufacturing processes are financially viable and sustainable, and the regulatory demands that must be met to ensure that pharmaceuticals manufactured in plants are safe, efficacious and meet the quality standards demanded by the regulators. With the recent approval of the first plant-derived recombinant pharmaceutical protein designated for human use, we are now entering a new era in which plants not only meet all the demands of a commercial pharmaceutical manufacturing process but also provide unique benefits that allow the displacement of established platform technologies in niche markets. In this article, we consider the commercial aspects of molecular farming, specifically those required to make plants more competitive and attractive to industry.

  1. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... approval and approval plates. 18.99 Section 18.99 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... disapproval; letters of approval and approval plates. Upon completion of each inspection conducted in... District Manager who authorized its issuance and send the field approval plate to the applicant. The...

  2. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... approval and approval plates. 18.99 Section 18.99 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... disapproval; letters of approval and approval plates. Upon completion of each inspection conducted in... District Manager who authorized its issuance and send the field approval plate to the applicant. The...

  3. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approval and approval plates. 18.99 Section 18.99 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... disapproval; letters of approval and approval plates. Upon completion of each inspection conducted in... District Manager who authorized its issuance and send the field approval plate to the applicant. The...

  4. Drugs Approved for Prostate Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  5. Drugs Approved for Thyroid Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  6. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  7. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation?

    PubMed

    Arnold, Denis G; Troyer, Jennifer L

    2016-04-01

    The pharmaceutical industry has been criticized for developing and aggressively marketing drugs that do not provide significant health benefits relative to existing drugs but retain the benefits of patent protection. Critics argue that drug marketing increases health care expenditures and provides a disincentive for pioneering drug innovation. However, evidence that marketing expenditures have any relationship to new drug approvals has been anecdotal. We hypothesized that, at publicly traded pharmaceutical firms, increased marketing expenditures will result in a reduced volume of pioneering new drugs in comparison to less innovative new drugs. We also hypothesized that additional research and development spending will result in an increased volume of pioneering new drugs in comparison to less innovative drugs. Results confirm our hypotheses. Specific policy recommendations for altering firms' incentives for the development of pioneering drugs are provided.

  8. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

    There is no abstract available for this product. If further information is requested, please refer to the bibliographic citation and contact the person listed under Contact field. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, interviews for media, responding to public inquiries. S

  9. OSI-774 OSI Pharmaceuticals.

    PubMed

    Norman, P

    2001-02-01

    OSI-774 (formerly CP-358774), a quinazoline derivative, is an orally active epidermal growth factor receptor (EGFR) inhibitor which was originally under joint development by Pfizer and OSI Pharmaceuticals (formerly Oncogene Science) for the potential treatment of cancer (eg, ovarian, non-small cell lung cancer (NSCLC) and head and neck). It is being evaluated in phase II trials [304305], [372201]. On 8 January 2001, OSI announced that it had signed an agreement with Roche and Genentech for the global co-development and marketing of OSI-774. The agreement with Genentech covers the United States, that with Roche the rest of the world [395371], [395526]. In June 2000, OSI gained all development and marketing rights for OSI-774 following Pfizer's merger with Warner-Lambert [371439]. In September 2000, Pfizer transferred the IND dossierfor OSI-774 to OSI ahead of the timeline agreed in the June 2000 development and marketing rights agreement [383786]. The phase II trials will assess OSI-774 both as a single agent and in combination with existing chemotherapy regimens [347783]. Phase III trials are expected to be initiated in 2001 [347783]. In October 2000, Lehman Brothers predicted that OSI-774 would move into pivotal trials in thefirst half of 2001 and that the drug would be launched in 2003. The analysts also estimated worldwide sales of US $66 million, $285 million and $461 million in 2003, 2004 and 2005, respectively, and peak sales in excess of US $500 million [395189].

  10. PHARMACEUTICALS AS ENVIRONMENTAL ...

    EPA Pesticide Factsheets

    There is no abstract available for this product. If further information is requested, please refer to the bibliographic citation and contact the person listed under Contact field. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, interviews for media, responding to public inquiries. S

  11. Biricodar. Vertex Pharmaceuticals.

    PubMed

    Dey, Saibal

    2002-05-01

    Vertex is developing biricodar as a chemosensitizing agent designed to restore the effectiveness of chemotherapeutic agents in tumor multidrug resistance. By November 1998, phase II trials had commenced for biricodar, in combination with chemotherapy, for five common cancer indications: breast, ovarian, soft-tissue sarcomas, small cell lung cancer and prostate cancer. Phase II trials were ongoing in January 2002. By March 2000, Vertex was the sole developer of biricodar, as an agreement made in 1996 with BioChem Pharma (now Shire Pharmaceuticals), for the development and marketing of biricodar in Canada was terminated. Biricodar is the free base compound, which also has a citrate salt analog known as VX-710-3. Vertex has published three patents, WO-09615101, WO-09636630 and WO-09736869, disclosing derivatives of biricodar that are claimed for the treatment of multidrug resistant protein and P-glycoprotein-mediated multidrug resistant tumors. In January 2002, a Banc of America analyst report forecast that biricodar had a 30% chance of reaching the market with a launch date in the second half of 2005, with peak sales estimated at $250 million.

  12. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

    The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environmental pollutants (primarily in surface but also in ground waters) as a result of their widespread, continuous, combined usage in a broad range of human and veterinary therapeutic activities and practices. With respect to the risk-assessment paradigm the growing body of published work has focused primarily on the origin and occurrence of these substances. Comparatively less is known about human and ecological exposure, and even less about the documented or potential hazards associated with trace exposure to these anthropogenic substances, many of which are highly bioactive and perpetually present in many aquatic locales. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/m

  13. PHARMACEUTICALS AS UBIQUITOUS POLLUTANTS ...

    EPA Pesticide Factsheets

    Those chemical pollutants that are regulated under various international, federal, and state programs represent but a small fraction of the universe of chemicals that occur in the environment as a result of both natural processes and human influence. Although this galaxy of targeted chemicals might be minuscule compared with the universe of both known and yet-to-be identified chemicals, an implicit assumption is that these selective lists of chemicals are responsible for the most significant share of risk with respect to environmental or economic impairment or to human health. Pharmaceuticals and personal care products (PPCPs) comprise a particularly large and diverse array of unregulated pollutants that occur in the environment from the combined activities and actions of multitudes of individuals as well as from veterinary and agricultural use. Although the concentration of any individual PPCP rarely ever exceeds the sub-ppm level (if present in drinking water, concentrations of individual PPCPs are generally less than the ppt-ppb level), evidence is accumulating that these trace-Ievel pollutants are ubiquitous, they can have a continuous presence regardless of environmental half-lives ( e.g., where sanitary wastewaters enter the environment), and the numbers of distinct and varied chemical entities could be extremely large (given that thousands are in commercial use). The research focused on in the subtasks is the development and application of state-of the-ar

  14. Recognizing misleading pharmaceutical marketing online.

    PubMed

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2014-01-01

    In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

  15. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

    Oral presentation at SETAC North America 32nd annual meeting, describing our prioritization of active pharmaceutical ingredients (APIs), based on estimates of risks posed by API residues originating from municipal wastewater. Goals of this project include prioritization of APIs f...

  16. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

    Oral presentation at SETAC North America 32nd annual meeting, describing our prioritization of active pharmaceutical ingredients (APIs), based on estimates of risks posed by API residues originating from municipal wastewater. Goals of this project include prioritization of APIs f...

  17. [PICS: pharmaceutical inspection cooperation scheme].

    PubMed

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

  18. 78 FR 60684 - Adoption of Updated EDGAR Filer Manual

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... COMMISSION 17 CFR Part 232 Adoption of Updated EDGAR Filer Manual AGENCY: Securities and Exchange Commission... revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual and related... incorporation by reference of the EDGAR Filer Manual is approved by the Director of the Federal Register as of...

  19. Evidence-based pharmaceutical care: The next chapter in pharmacy practice.

    PubMed

    Al-Quteimat, Osama Mohammad; Amer, Amer Mostafa

    2016-07-01

    Pharmacy is a very dynamic profession and the role of the pharmacist is improving with the expansion of the scope of services and the introduction of new subspecialties over time. Moving from being medication dispensers to outcome-oriented and patient-focused care providers; pharmacists will carry more responsibility and commitment to improve their knowledge and practice. Being updated and evidence-based is a key tool to achieve effective pharmaceutical care services. The primary purpose of this article is to highlight the concept of "evidence based pharmaceutical care" as professional practice to improve the quality of pharmaceutical care. Literature for relevant evidence was searched by Medline (through PubMed), Cochrane library using the keywords: pharmaceutical care, evidence-based and pharmacy practice. Also a manual search through major journals for articles referenced in those located through PubMed was done. There is strong data showing that pharmaceutical care lead to improvement in health outcomes and cost-effective therapy. More efforts, policies and qualified staff are needed to establish the "evidence-based pharmaceutical care" as new daily professional practice. Evidence to support pharmacists in their emerging role as care providers is available to improve the efficacy and quality of pharmaceutical care. Education and specialized training practicing evidence based approach are vital to prepare pharmacists to provide high quality pharmaceutical care. As care providers, pharmacists are effective in providing high quality patient care and being members in multidisciplinary clinical teams is needed to give them the opportunity. Evidence based pharmaceutical care is a natural and logical emerging concept in the modern pharmacy practice to achieve high quality and more effective pharmaceutical care but still more efforts and resources are needed to promote new attitude toward more professional career.

  20. Bexarotene ligand pharmaceuticals.

    PubMed

    Hurst, R E

    2000-12-01

    Bexarotene (LGD-1069), from Ligand, was the first retinoid X receptor (RXR)-selective, antitumor retinoid to enter clinical trials. The company launched the drug for the treatment of cutaneous T-cell lymphoma (CTCL), as Targretin capsules, in the US in January 2000 [359023]. The company filed an NDA for Targretin capsules in June 1999, and for topical gel in December 1999 [329011], [349982] specifically for once-daily oral administration for the treatment of patients with early-stage CTCL who have not tolerated other therapies, patients with refractory or persistent early stage CTCL and patients with refractory advanced stage CTCL. The FDA approved Targretin capsules at the end of December 1999 for once-daily oral treatment of all stages of CTCL in patients refractory to at least one prior systemic therapy, at an initial dose of 300 mg/m2/day. After an NDA was submitted in December 1999 for Targretin gel, the drug received Priority Review status for use as a treatment of cutaneous lesions in patients with stage IA, IB or IIA CTCL [354836]. The FDA issued an approvable letter in June 2000, and granted marketing clearance for CTCL in the same month [370687], [372768], [372769], [373279]. Ligand had received Orphan Drug designation for this indication [329011]. At the request of the FDA, Ligand agreed to carry out certain post-approval phase IV and pharmacokinetic studies [351604]. The company filed an MAA with the EMEA for Targretin Capsules to treat lymphoma in November 1999 [348944]. The NDA for Targretin gel is based on a multicenter phase III trial that was conducted in the US, Canada, Europe and Australia involving 50 patients and a multicenter phase I/II clinical program involving 67 patients. Targretin gel was evaluated for the treatment of patients with early stage CTCL (IA-IIA) who were refractory to, intolerant to, or reached a response plateau for at least 6 months on at least two prior therapies. Efficacy results exceeded the protocol-defined response

  1. Drugs Approved for Leukemia

    Cancer.gov

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  2. Drugs Approved for Neuroblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Retinoblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  4. Joule Unlimited Technologies Approval

    EPA Pesticide Factsheets

    This March 29 letter from EPA approves the petition from Joule Unlimited Technologies, Inc. regarding ethanol produced through the Joule Helioculture Process under the Clean Air Act for renewable fuel [D-code 5] RINs under the RFS program.

  5. Approved Drugs for Adults

    MedlinePlus

    ... are 2 types of immune modulator drugs called “interferon” that are given as an injection for 6 ... year or two. (Approved in 1998) Immune Modulators (Interferons) Pegylated Interferon (Pegasys) is given by injection once ...

  6. Newborn Screening Tests Approved

    MedlinePlus

    ... The screens are used to detect four rare metabolic disorders To use the sharing features on this page, ... of screening tests designed to detect four rare metabolic disorders in newborns has been approved by the U.S. ...

  7. Emergency medical kit for commercial airlines: an update.

    PubMed

    Thibeault, Claude; Evans, Anthony

    2007-12-01

    In 1998, the Air Transport Medicine (ATM) Committee of the Aerospace Medical Association (AsMA) made its first recommendations concerning medical kits for commercial airlines. These were updated in 2002 and the ATM has continued to monitor medical kit usage, as well as pharmaceutical developments, and a further revision is now needed. This has taken into account ongoing work of the International Civil Aviation Organization and recommendations of the International Air Transport Association in the field of passenger and crew health. Based on the above, the Committee proposes the following update to its 2002 recommendations.

  8. Emergency medical kit for commercial airlines: an update.

    PubMed

    Thibeault, Claude

    2002-06-01

    As expected, the issue of medical kits for commercial airlines continues to attract attention, especially in light of the recent United States regulation on the subject. As promised in its first recommendation in 1998, the Air Transport Medicine (ATM) Committee has continued to monitor medical kit usage as well as pharmaceutical scientific developments and wishes to propose an update to its 1998 recommendation. Lists of contents are provided for emergency medical kits of two types: 1) those without defibrillator/monitor or monitor; and 2) those with defibrillator/monitor or monitor alone. Follow up and updates on this issue will be an ongoing task of the ATM Committee.

  9. Aripiprazole (Otsuka Pharmaceutical Co).

    PubMed

    Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih

    2002-01-01

    Otsuka Pharmaceuticals in collaboration with Bristol-Myers Squibb is developing aripiprazole, a dual dopamine autoreceptor agonist and postsynaptic D2 receptor antagonist, for the potential treatment of psychoses including schizophrenia [281327], [340364]. A regulatory filing for schizophrenia in the US was submitted at the end of 2001 [340364]. The compound entered phase III trials in Japan in 1995 [192966]. Although presynaptic dopamine autoreceptor agonists may be efficacious in the treatment of schizophrenia, they may also potentially increase the risk for exacerbation of psychosis through stimulation of postsynaptic dopaminergic receptors [245791], [350478], [350479]. However, earlier neuropharmacology studies have shown that aripiprazole can act as a presynaptic D2 agonist while displaying an antagonistic effect at the postsynaptic D2 receptors [281327], [337126], [350479], [424587], [424588]. In animal models, aripiprazole inhibits the apomorphine-induced stereotypy, without causing catalepsy [281327], [337126]. Moreover, in contrast to classical antipsychotics that produce disabling movement disorders, aripiprazole does not cause an upregulation of D2 receptors or an increase in expression of the c-fos mRNA in the striatum, in agreement with the low risk for extrapyramidal side effects (EPS) during aripiprazole treatment [245781], [262096], [350481], [350483]. Collectively, aripiprazole is an important atypical antipsychotic candidate with a favorable safety profile. Moreover, the mechanism of action of aripiprazole differentiates it from both typical and atypical antipsychotics and hence, may provide important leads for pharmacotherapy of schizophrenia and other psychotic disorders. In January 2000, Lehman Brothers predicted peak sales of aripiprazole could reach US $500 million [357788]. In February 2001, Credit Suisse First Boston predicted sales of US $403 million in 2005 [399484].

  10. Pharmacodynamics of Memantine: An Update

    PubMed Central

    Rammes, G; Danysz, W; Parsons, C.G

    2008-01-01

    Memantine received marketing authorization from the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of moderately severe to severe Alzheimer´s disease (AD) in Europe on 17th May 2002 and shortly thereafter was also approved by the FDA for use in the same indication in the USA. Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist with strong voltage-dependency and fast kinetics. Due to this mechanism of action (MOA), there is a wealth of other possible therapeutic indications for memantine and numerous preclinical data in animal models support this assumption. This review is intended to provide an update on preclinical studies on the pharmacodynamics of memantine, with an additional focus on animal models of diseases aside from the approved indication. For most studies prior to 1999, the reader is referred to a previous review [196]. In general, since 1999, considerable additional preclinical evidence has accumulated supporting the use of memantine in AD (both symptomatic and neuroprotective). In addition, there has been further confirmation of the MOA of memantine as an uncompetitive NMDA receptor antagonist and essentially no data contradicting our understanding of the benign side effect profile of memantine. PMID:19305788

  11. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.

  12. ISIS-3521. Isis Pharmaceuticals.

    PubMed

    Li, K; Zhang, J

    2001-10-01

    ISIS-3521 is a 20-mer antisense phosphorothioate oligonucleotide PKCa expression inhibitor, under development by Isis (formerly in collaboration with Novartis) for the potential treatment of solid tumors that are refractory to, or recurrent with, standard treatment regimens [175741]. In November 1999, Novartis announced that it would end its codevelopment of ISIS-3521 [348221], [348222]. In August 2001, Eli Lilly in-licensed ISIS-3521 [420062]. In October 2000, phase III trials of ISIS-3521, in combination with carboplatin and paclitaxel, were initiated for the treatment of non-small cell lung cancer (NSCLC) [386128]. The FDA granted ISIS-3521 Fast Track review status for NSCLC in November 2000 [388930]. In April 2001, Bear Sterns & Co predicted US approval of ISIS-3521 in 2002 [411081]. In August 2001, Eli Lilly and Isis entered into a four-year strategic alliance that includes ISIS-3521. For the license of ISIS-3521, Isis will receive $25 million in upfront fees and will be reimbursed for remaining phase III development and registration costs [420062].

  13. Marine-Derived Pharmaceuticals – Challenges and Opportunities

    PubMed Central

    Lindequist, Ulrike

    2016-01-01

    Marine biosphere is the largest one of the earth and harbors an enormous number of different organisms. Living conditions differ fundamentally from those in terrestrial environment. The production of specific secondary metabolites is an important adaption mechanism of marine organisms to survive in the sea. These metabolites possess biological activities which make them interesting as possible drugs for human. The review presents sources, chemistry, production and pharmacology of FDA approved marine derived pharmaceuticals arranged according to their therapeutic indication. Four of the presently seven approved drugs are used for the treatment of cancer. Each another one is applicated for treatment of viral diseases, chronic pain and to lower triglyceride level in blood. Some other products are of interest in diagnostic and as experimental tools. Besides, this article describes challenges in drug development from marine sources, especially the supply problem. PMID:27795450

  14. Duchenne muscular dystrophy drugs face tough path to approval.

    PubMed

    Hodgkinson, L; Sorbera, L; Graul, A I

    2016-03-01

    Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021.

  15. Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.

    PubMed

    Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan

    2014-03-01

    Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Punishments: What Predicts Adult Approval.

    ERIC Educational Resources Information Center

    Buntain-Ricklefs, Joanne J.; And Others

    1994-01-01

    A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

  17. [Doctor-initiated clinical trials and the revised pharmaceutical affairs law].

    PubMed

    Takano, Toshimi; Saijo, Nagahiro

    2003-10-01

    In Japan, clinical trials aiming at application for approval of new drugs take a long time and a lot of money, and their quality thought to be poor. Japanese pharmaceutical companies tend to conduct more clinical studies in the United States and/or Europe than in Japan. The Ministry of Health, Labour and Welfare (MHLW) announced a three-year plan to facilitate clinical trials in Japan; the establishment of a large-scale clinical trial network, the improvement of the clinical research infrastructure, and the utilization of doctor-initiated clinical trials. The revised Pharmaceutical Affairs Law enables doctors and medical institutions to perform clinical trials using unapproved products spontaneously without any corporate sponsorship. Drugs needed by some patients but unapproved because they are unprofitable for companies are expected to be approved under this system. MHLW stipulated the ethical and scientific quality standard of doctor-initiated clinical trials, which is consistent with the principles of the Declaration of Helsinki, and Good Clinical Practice (GCP). To establish a system that allows expedited approval of safer and more effective products, the integration of the functions of the current review bodies, such as the Organization for Pharmaceutical Safety and Research (OPSR) and the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), into an independent administrative agency is scheduled.

  18. Diesel Engine Technology Update

    DTIC Science & Technology

    1987-07-01

    AFWAL-TR-87-20 54 83-021-DET DIESEL ENGINE TECHNOLOGY UPDATE Kaupert, Andrew W., Lt. Col. USAFR Air Force Reserves Detroit Detachment 2 Ann Arbor, MI...nn AFR OH 45433-6563 63723F 3139 1 01 01 11. TITLE (Include Security Classification) DIESEL ENGINE TECHNOLOGY UPDATE 12. PERSONAL AUTHOR(S) Kaupert...methodology for technology prediction. The objective of the present report is to update the technology transfer/ 0 development status of diesel engine

  19. Pharmaceutical policies in European countries.

    PubMed

    Barros, Pedro Pita

    2010-01-01

    Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

  20. [Bioequivalence studies of pharmaceutical preparations].

    PubMed

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

  1. ISS Update: Suitport

    NASA Image and Video Library

    ISS Update commentator Lynnette Madison interviews Mallory Jennings, Suitport Human Testing Lead, about making spacewalks easier and more efficient with the Suitport. Questions? Ask us on Twitter @...

  2. Notable deals in the pharmaceutical industry in the fourth quarter of 2016.

    PubMed

    D'Souza, P

    2017-01-01

    During the fourth quarter of 2016, Cortellis Competitive Intelligence had 889 new deals added as part of its ongoing coverage of pharmaceutical licensing activity. This was an increase on both the last quarter (865) but a decrease from the same quarter for the previous year (915). This article will focus on highlighting a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers. An update on milestones, options and terminated deals of significance will also be presented, along with an early outlook on the next quarter's pharmaceutical licensing activity. Copyright 2017 Clarivate Analytics.

  3. Notable deals in the pharmaceutical industry in the second quarter of 2016.

    PubMed

    D'Souza, P

    2016-08-01

    During the second quarter of 2016, Cortellis Competitive Intelligence had 1,014 new deals added as part of its ongoing coverage of pharmaceutical licensing activity. This was on par with the last quarter (1,011) and a substantial increase on the same quarter for the previous 1 year (659). This article will focus on highlighting a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers. An update on milestone, options and terminated deals of significance will also be presented, along with an early outlook on the next quarter's pharmaceutical licensing activity.

  4. Transformation in the pharmaceutical industry: transformation-induced quality risks--a survey.

    PubMed

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J; Mouzughi, Yusra

    2013-01-01

    This paper is the fourth in a series that explores ongoing transformation in the pharmaceutical industry and its impact on pharmaceutical quality from the perspective of risk identification. The aim of this paper is to validate proposed quality risks through elicitation of expert opinion and define the resultant quality risk model. Expert opinion was obtained using a questionnaire-based survey with participants with recognized expertise in pharmaceutical regulation, product lifecycle, or technology. The results of the survey validate the theoretical and operational evidence in support of the four main pharmaceutical transformation triggers previously identified. The quality risk model resulting from the survey indicated a firm relationship between the pharmaceutical quality risks and regulatory compliance outcomes during the marketing approval and post-marketing phases of the product lifecycle and a weaker relationship during the pre-market evaluation phase. In this paper through conduct of an expert opinion survey the proposed quality risks carried forward from an earlier part of the research are validated and resultant quality risk model is defined. The survey results validate the theoretical and operational evidence previously identified. The quality risk model indicates that transformation-related risks have a larger regulatory compliance impact during product approval, manufacturing, distribution, and commercial use than during the development phase.

  5. Ibrutinib: first global approval.

    PubMed

    Cameron, Fiona; Sanford, Mark

    2014-02-01

    Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL.

  6. An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

    PubMed

    Lanthier, Michael; Miller, Kathleen L; Nardinelli, Clark; Woodcock, Janet

    2013-08-01

    For more than a decade, industry analysts and policy makers have raised concerns about declining pharmaceutical innovation, citing declining numbers of new molecular entities (NMEs) approved in the United States each year. Yet there is little consensus on whether this is the best measure of "innovation." We examined NME approvals during 1987-2011 and propose the three distinct subcategories of NMEs--first-in-class, advance-in-class, and addition-to-class--to provide more nuanced and informative insights into underlying trends. We found that trends in NME approvals were largely driven by addition-to-class, or "me too," drug approvals, while first-in-class approvals remained fairly steady over the study period. Moreover, the higher proportion of first-in-class drug approvals over the most recent decade is an encouraging sign of the health of the industry as a whole.

  7. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... shall forward the completed application form and other data to Approval and Certification Center which..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  8. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... shall forward the completed application form and other data to Approval and Certification Center which..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval...

  9. Planning and coordinating pharmaceutical purchasing.

    PubMed

    Buchanan, E C

    1984-09-01

    The planning and coordination of the pharmaceutical purchasing process are discussed. Planning for pharmaceutical purchasing should begin with decisions regarding why a purchasing policy is needed, what the institution's purchasing policy will be, and what departments will be involved in purchasing. General goals of purchasing and procedures for revising purchasing functions are presented, and the role of the pharmacy department, materials management, and other hospital departments in purchasing is discussed. Coordinating input on purchasing decisions from medical staff, administration, and clinical and technical pharmacy personnel to achieve purchasing goals and objectives is discussed. A well-designed pharmaceutical purchasing system provides for planned and scheduled purchases, competitive bidding, product standardization, group purchasing, information sharing, internal accountability, and quality assurance.

  10. Macro trends in pharmaceutical innovation.

    PubMed

    Cohen, Fredric J

    2005-04-01

    Extract: A lately recycled criticism of the pharmaceutical industry is that it is failing in its mission to innovate. In particular, critics question the industry's incentives to innovate, and they deride those innovations the industry makes as imitative. Industry advocates contend the opposite. The truth is that there are no generally accepted measures of innovation that would conclusively prove either side's point. However, I have found trends in several measures that support both sides of the innovation debate. Overall, the bulk of evidence suggests that the pharmaceutical industry continues to regard pioneering innovations as important (evidenced by the motivation, effort and ability of the industry to create such innovations). However, like other mature manufacturing industries, the pharmaceutical industry relies heavily on incremental innovations (what critics call "me-too" drugs) to sustain its profits. To a large extent, these incremental innovations are themselves medically beneficial and should be encouraged rather than dismissed as merely imitative.

  11. The pharmaceutical industry in Cuba.

    PubMed

    Tancer, R S

    1995-01-01

    Cuba has developed a relatively sophisticated pharmaceutical sector, originally to provide medicinal products for her own population and, more recently, to earn hard currency through exports. Cuba has achieved both of these goals despite the US trade embargo, which isolates Cuba from commercial relations with US firms. Cuba is opening its economy to firms from other countries through the use of joint ventures and other forms of cooperation. US firms are unable to avail themselves of these opportunities, and the opportunities are thus being lost. In the case of pharmaceuticals, the Cubans recognize that they need assistance, particularly in the areas of marketing and packaging. Allowing the participation of US firms in the Cuban pharmaceutical industry could enhance the possibility of improving worldwide health care.

  12. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  13. Dulaglutide: first global approval.

    PubMed

    Sanford, Mark

    2014-11-01

    Dulaglutide (Trulicity™) is a long-acting, glucagon-like peptide-1 (GLP-1) receptor agonist that has been developed by Eli Lilly and Company for the treatment of type 2 diabetes mellitus. It consists of a dipeptidyl peptidase-IV-protected GLP-1 analogue covalently linked to a human IgG4-Fc heavy chain by a small peptide linker. The subcutaneous formulation is approved for use in type 2 diabetes in the US, has been recommended for approval in the EU in this indication, and is under regulatory review in other countries. This article summarizes the milestones in the development of subcutaneous dulaglutide leading to this first approval for type 2 diabetes.

  14. Blinatumomab: first global approval.

    PubMed

    Sanford, Mark

    2015-02-01

    Blinatumomab (BLINCYTO™) is a novel, bispecific T-cell engaging antibody that binds cluster of differentiation (CD) 19 antigens on blast cells while also binding and activating the CD3/T cell receptor complex, causing cell lysis. The antibody is being developed by Amgen as a treatment for haematological cancers that originate from B cell lines. Blinatumomab was approved by the US FDA in December 2014 for the treatment of adults with Philadelphia chromosome (Ph)-negative relapsed/refractory B-cell precursor acute lymphoblastic leukaemia (BCP-ALL). It is awaiting approval for this indication in the EU and is in phase III development in various countries. This article summarizes the milestones in the development of blinatumomab leading to its first approval for the treatment of Ph-negative BCP-ALL.

  15. Apremilast: first global approval.

    PubMed

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  16. Pomalidomide: first global approval.

    PubMed

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  17. Chapter A5. Section 6.1.F. Wastewater, Pharmaceutical, and Antibiotic Compounds

    USGS Publications Warehouse

    Lewis, Michael Edward; Zaugg, Steven D.

    2003-01-01

    The USGS differentiates between samples collected for analysis of wastewater compounds and those collected for analysis of pharmaceutical and antibiotic compounds, based on the analytical schedule for the laboratory method. Currently, only the wastewater laboratory method for field-filtered samples (SH1433) is an approved, routine (production) method. (The unfiltered wastewater method LC 8033 also is available but requires a proposal for custom analysis.) At this time, analysis of samples for pharmaceutical and antibiotic compounds is confined to research studies and is available only on a custom basis.

  18. Methods of Rapid Microbiological Assay and Their Application to Pharmaceutical and Medical Device Fabrication.

    PubMed

    Shintani, Hideharu

    2016-01-01

     There are several rapid microbiological methods becoming available that have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some methods may require expensive equipment and offer full automation, and others represent only a small investment. The regulatory view of these methods is changing and they still officially have not been approved in medical and pharmaceutical area, but it will still be up to the microbiologist to demonstrate that the method chosen is fit for the purpose intended.

  19. 77 FR 6057 - Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... Foreign-Trade Zones Board Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation, (Pharmaceutical and Biological Intravenous Product Manufacturing), Chicago, IL Pursuant to its... District, grantee of Foreign-Trade Zone 22, has requested manufacturing authority on behalf of...

  20. Current Pharmaceutical Treatments and Alternative Therapies of Parkinson's Disease.

    PubMed

    Dong, Jie; Cui, Yanhua; Li, Song; Le, Weidong

    2016-01-01

    Over the decades, pharmaceutical treatments, particularly dopaminergic (DAergic) drugs have been considered as the main therapy against motor symptoms of Parkinson's disease (PD). It is proposed that DAergic drugs in combination with other medications, such as monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, anticholinergics and other newly developed non-DAergic drugs can make a better control of motor symptoms or alleviate levodopa-induced motor complications. Moreover, non-motor symptoms of PD, such as cognitive, neuropsychiatric, sleep, autonomic and sensory disturbances caused by intrinsic PD pathology or drug-induced side effects, are gaining increasing attention and urgently need to be taken care of due to their impact on quality of life. Currently, neuroprotective therapies have been investigated extensively in pre-clinical studies, and some of them have been subjected to clinical trials. Furthermore, non-pharmaceutical treatments, including deep brain stimulation (DBS), gene therapy, cell replacement therapy and some complementary managements, such as Tai chi, Yoga, traditional herbs and molecular targeted therapies have also been considered as effective alternative therapies to classical pharmaceutics. This review will provide us updated information regarding the current drugs and non-drugs therapies for PD.

  1. Current Pharmaceutical Treatments and Alternative Therapies of Parkinson's Disease

    PubMed Central

    Dong, Jie; Cui, Yanhua; Li, Song; Le, Weidong

    2016-01-01

    Over the decades, pharmaceutical treatments, particularly dopaminergic (DAergic) drugs have been considered as the main therapy against motor symptoms of Parkinson's disease (PD). It is proposed that DAergic drugs in combination with other medications, such as monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, anticholinergics and other newly developed non-DAergic drugs can make a better control of motor symptoms or alleviate levodopa-induced motor complications. Moreover, non-motor symptoms of PD, such as cognitive, neuropsychiatric, sleep, autonomic and sensory disturbances caused by intrinsic PD pathology or drug-induced side effects, are gaining increasing attention and urgently need to be taken care of due to their impact on quality of life. Currently, neuroprotective therapies have been investigated extensively in pre-clinical studies, and some of them have been subjected to clinical trials. Furthermore, non-pharmaceutical treatments, including deep brain stimulation (DBS), gene therapy, cell replacement therapy and some complementary managements, such as Tai chi, Yoga, traditional herbs and molecular targeted therapies have also been considered as effective alternative therapies to classical pharmaceutics. This review will provide us updated information regarding the current drugs and non-drugs therapies for PD. PMID:26585523

  2. Quality specifications for peptide drugs: a regulatory-pharmaceutical approach.

    PubMed

    Vergote, Valentijn; Burvenich, Christian; Van de Wiele, Christophe; De Spiegeleer, Bart

    2009-11-01

    Peptide drugs, as all types of pharmaceuticals, require adequate specifications (i.e. quality attributes, procedures and acceptance criteria) as part of their quality assurance to ensure the safety and efficacy of drug substances (i.e. active pharmaceutical ingredients) and drug products (i.e. finished pharmaceutical dosage forms). Compendial monographs are updated regularly to keep up with the most recent advances in peptide synthesis (e.g. reduced by-products) and analytical technology. Nevertheless, currently applied pharmacopoeial peptide specifications are barely harmonized yet (e.g. large differences between the European Pharmacopoeia and the United States Pharmacopeia), increasing the manufacturers' burden of performing analytical procedures in different ways, using different acceptance criteria. Additionally, the peptide monographs are not always consistent within a single pharmacopoeia. In this review, we highlight the main differences and similarities in compendial peptide specifications (including identification, purity and assay). Based on comparison, and together with additional information from peptide drug substance manufacturers and public evaluation reports on registration files of non-pharmacopoeial peptide drugs, a consistent monograph structure is proposed.

  3. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    PubMed

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

  4. Etelcalcetide: First Global Approval.

    PubMed

    Blair, Hannah A

    2016-12-01

    Etelcalcetide (Parsabiv™) is a novel second generation calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT), a complication of chronic kidney disease (CKD). Etelcalcetide reduces circulating levels of parathyroid hormone and calcium by binding directly to the calcium-sensing receptor. Intravenous etelcalcetide has been approved in the EU for the treatment of SHPT in adult patients with CKD on haemodialysis therapy. Regulatory applications for etelcalcetide in SHPT are also under review in the USA and Japan. This article summarizes the milestones in the development of etelcalcetide leading to this first global approval for the treatment of SHPT.

  5. [Off-label use: update and relevance for urology].

    PubMed

    Krege, S; Rohde, D

    2007-07-01

    The use of pharmaceuticals beyond the approved indication and conditions (off-label use) is of increasing public interest in times of necessary financial constraints in public health together with the high requirements for drug safety to protect the patient. Remarkably, more than half of the therapies in oncology are performed as off-label use. The discussion on off-label use is controversial and based on different points of interests. Evaluation of therapeutic agents by the pharmaceutical industry is predominantly driven by marketing and business requirements. As a consequence, treatment of rare diseases is often only possible by off-label use, creating more or less an off-label need. Reimbursement by health-care insurance is based on the approval of a pharmaceutical substance for a particular situation, because only the rigorous licensing process assures that the verified efficacy is higher than the, often severe, adverse side effects. It is a well known fact that the sometimes adverse events, which occur on administration of substances in an off-label fashion, are not included in the information on the regular use of a given drug. Finally, physicians request a controlled off-label use, which only allows experienced colleagues and (sub)-specialized oncologists to use pharmaceuticals in an off-label fashion. Up to date no legal documents exist that provide regulations for such an off-label usage.

  6. Country Update: Israel 2005

    ERIC Educational Resources Information Center

    Marar, Marianne Maurice

    2005-01-01

    Country Updates is a new section of "Intercultural Education." Starting in "Intercultural Education," Volume 16 No. 5, this column will focus on recent developments during the last two to three years in the field of intercultural education in one particular country. These updates can include recent policy decisions, the main…

  7. Hot-melt extrusion--basic principles and pharmaceutical applications.

    PubMed

    Lang, Bo; McGinity, James W; Williams, Robert O

    2014-09-01

    Originally adapted from the plastics industry, the use of hot-melt extrusion has gained favor in drug delivery applications both in academia and the pharmaceutical industry. Several commercial products made by hot-melt extrusion have been approved by the FDA, demonstrating its commercial feasibility for pharmaceutical processing. A significant number of research articles have reported on advances made regarding the pharmaceutical applications of the hot-melt extrusion processing; however, only limited articles have been focused on general principles regarding formulation and process development. This review provides an in-depth analysis and discussion of the formulation and processing aspects of hot-melt extrusion. The impact of physicochemical properties of drug substances and excipients on formulation development using a hot-melt extrusion process is discussed from a material science point of view. Hot-melt extrusion process development, scale-up, and the interplay of formulation and process attributes are also discussed. Finally, recent applications of hot-melt extrusion to a variety of dosage forms and drug substances have also been addressed.

  8. 78 FR 12238 - Approval and Promulgation of Air Quality Implementation Plans; Charlotte, Raleigh/Durham and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...EPA is taking direct final action to approve a limited maintenance plan update submitted by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR), on August 2, 2012. The limited maintenance plan update is for the Charlotte, Raleigh/Durham and Winston-Salem carbon monoxide (CO) maintenance areas. Specifically, the State submitted a limited maintenance plan update for CO, showing continued attainment of the 8-hour CO National Ambient Air Quality Standard (NAAQS) for the Charlotte, Raleigh/Durham and Winston-Salem Areas. The 8-hour CO NAAQS is 9 parts per million (ppm). EPA is taking direct final action to approve the limited maintenance plan update because it is consistent with the Clean Air Act (CAA or Act), and EPA's policy for limited maintenance plans.

  9. REG Geismar Approval

    EPA Pesticide Factsheets

    This April 13, 2017 letter from EPA approves the petition from Renewable Energy Group, Inc. for renewable diesel produced from non-food grade corn oil as biomass-based diesel under the Clean Air Act and the Renewable Fuel Standard Program.

  10. Heartland Winthrop Approval

    EPA Pesticide Factsheets

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  11. Poet Leipsic Approval

    EPA Pesticide Factsheets

    This August 9, 2016 letter from EPA approves,wtih modifications, the petition from Poet Biorefining-Leipsic, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs

  12. Poet Fostoria Approval

    EPA Pesticide Factsheets

    This August 9, 2016 letter from EPA approves, with modifications, the petition from Poet Biorefining-Fostoria, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6)

  13. CORN, LP Goldfield Approval

    EPA Pesticide Factsheets

    This November 19, 2015 letter from EPA approves the petition from CORN, LP, Goldfield facility, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS pro

  14. FHR Iowa Falls Approval

    EPA Pesticide Factsheets

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  15. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  16. GI Course Approvals.

    ERIC Educational Resources Information Center

    Orlans, Harold; And Others

    The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

  17. Gevo, Inc. Approval

    EPA Pesticide Factsheets

    This December 22, 2016 letter from EPA approves the petition from Gevo, Inc. for butanol produced from corn starch and/or grain sorghum as renewable fuel and in some cases advanced biofuel under the Clean Air Act and the Renewable Fuel Standard Program.

  18. Venetoclax: First Global Approval.

    PubMed

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL.

  19. Didion Cambria Approval

    EPA Pesticide Factsheets

    This May 9, 2016 letter from EPA approves the petition from Didion Ethanol, LLC, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  20. Poet Lake Crystal Approval

    EPA Pesticide Factsheets

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

  1. Basics of Compounding: Clinical Pharmaceutics, Part 2.

    PubMed

    Allen, Loyd V

    2016-01-01

    This article represents part 2 of a 2-part article on the topic of clinical pharmaceutics. Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Part 1 of this series of articles discussed incompatibilities which can directly affect a clinical outcome and utilized pharmaceutics case examples of the application and importance of clinical pharmaceutics covering different characteristics. Part 2 continues to illustrate the scientific principles and clinical effects involved in clinical pharmaceutics. Also covered in this article are many of the scientific principles in typical to patient care. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  2. Pharmaceutical Research and Manufacturers of America

    MedlinePlus

    ... The New Era of Medicine SHARE THIS The Pharmaceutical Research and Manufacturers of America, PhRMA, represents the ... PhRMA Privacy Policy Terms of Service Site Map Pharmaceutical Research and Manufacturers of America® 950 F Street, ...

  3. Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

    EPA Pesticide Factsheets

    Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.

  4. Endocrine-Active Pharmaceuticals: An Environmental Concern?

    EPA Science Inventory

    Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

  5. Endocrine-Active Pharmaceuticals: An Environmental Concern?

    EPA Science Inventory

    Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

  6. Pharmaceutical care in smoking cessation

    PubMed Central

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

  7. Immunotoxicology in the pharmaceutical industry.

    PubMed Central

    Norbury, K C

    1982-01-01

    Development of an immunotoxicology program within the pharmaceutical industry is described. With few guidelines in the area and a multitude of factors to consider, a basic screen for evaluating immune competence in species routinely used in toxicologic studies has been proposed. The future of immunotoxicology depends upon the ability of the selected immune function tests to be predictive of human risk. PMID:7037389

  8. Financing pharmaceuticals in transition economies.

    PubMed

    Kanavos, P

    1999-06-01

    This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.

  9. Modeling picking on pharmaceutical tablets

    NASA Astrophysics Data System (ADS)

    Swaminathan, Shrikant

    Tablets are the most popular solid dosage form in the pharmaceutical industry because they are cheap to manufacture, chemically and mechanically stable and easy to transport and fairly easy to control dosage. Pharmaceutical tableting operations have been around for decades however the process is still not well understood. One of the common problems faced during the production of pharmaceutical tablets by powder compaction is sticking of powder to the punch face, This is known as 'sticking'. A more specialized case of sticking is picking when the powder is pulled away form the compact in the vicinity of debossed features. In the pharmaceutical industry, picking is solved by trial and error which is an expensive, labor intensive and time consuming affair. The objective of this work was to develop, validate, and implement a modeling framework for predicting picking in powder compacts. The model was developed in Abaqus a commercially available finite element package. The resulting model was used to investigate the influence of debossed feature geometry viz. the stroke angle and degree of pre-pick, and, influence of lubricant on picking. (Abstract shortened by ProQuest.).

  10. Patrick Couvreur: inspiring pharmaceutical innovation.

    PubMed

    Stanwix, Hannah

    2014-05-01

    Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.

  11. Bioremediation of industrial pharmaceutical drugs.

    PubMed

    Mansour, Hedi Ben; Mosrati, Ridha; Barillier, Daniel; Ghedira, Kamel; Chekir-Ghedira, Leila

    2012-07-01

    Recently, attention has been drawn toward the occurrence of pharmaceuticals in the environment. In recent years, many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in wastewater (PW), surface water, ground water, and in soil. The pharmaceutical sector is currently expanding in Tunisia, with more than 34 industries. The aim of this work was to evaluate the ability of Pseudomonas putida mt-2 to treat PW. P. putida was very efficient in reducing chemical oxygen demand (COD), total dissolved solids (TDS), and turbidity of solution (85.5, 89.1, and 81.5%, respectively). Genotoxicity of effluent, before and after biodegradation, was evaluated in vivo in mouse bone marrow by assessing the percentage of cells bearing different chromosome aberrations. Results indicated that PW showed a significant ability to induce DNA damage. In addition, PW induced a remarkable lipid peroxidation (LPO) effect, however, activities of both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) were unchanged when treated with PW, compared to nontreated PW. This toxicity was imputed to the presence of pharmaceutical compounds in wastewater. However, chromosome aberration, as well as LPO of PW, were significantly reduced after bioremediation. Thus, the use of this strain for testing on the industrial scale seems possible and advantageous.

  12. Organic herbicide update

    USDA-ARS?s Scientific Manuscript database

    Weed research is the top research priority among organic producers. Very few chemical weed control options are approved for organic use (corn gluten meal, vinegar, clove oil, and most recently ammonium pelargonate ), but additional compounds are under investigation and pursuing organic approval. C...

  13. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

    PubMed

    Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

    2016-12-30

    Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public.

  14. 75 FR 62444 - 60-Day Notice of Proposed Information Collection: Form DS-3057, Medical Clearance Update, OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ... Collection: Form DS-3057, Medical Clearance Update, OMB 1405-0131 ACTION: Notice of request for public... Clearance Update. OMB Control Number: 1405-0131. Type of Request: Extension of Currently Approved Collection..., Office of Medical Clearances, SA-15 Room 400, 1800 North Kent St., Rosslyn, VA. 22209. Fax:...

  15. Changing tides: Adaptive monitoring, assessment, and management of pharmaceutical hazards in the environment through time.

    PubMed

    Gaw, Sally; Brooks, Bryan W

    2016-04-01

    Pharmaceuticals are ubiquitous contaminants in aquatic ecosystems. Adaptive monitoring, assessment, and management programs will be required to reduce the environmental hazards of pharmaceuticals of concern. Potentially underappreciated factors that drive the environmental dose of pharmaceuticals include regulatory approvals, marketing campaigns, pharmaceutical subsidies and reimbursement schemes, and societal acceptance. Sales data for 5 common antidepressants (duloxetine [Cymbalta], escitalopram [Lexapro], venlafaxine [Effexor], bupropion [Wellbutrin], and sertraline [Zoloft]) in the United States from 2004 to 2008 were modeled to explore how environmental hazards in aquatic ecosystems changed after patents were obtained or expired. Therapeutic hazard ratios for Effexor and Lexapro did not exceed 1; however, the therapeutic hazard ratio for Zoloft declined whereas the therapeutic hazard ratio for Cymbalta increased as a function of patent protection and sale patterns. These changes in therapeutic hazard ratios highlight the importance of considering current and future drivers of pharmaceutical use when prioritizing pharmaceuticals for water quality monitoring programs. When urban systems receiving discharges of environmental contaminants are examined, water quality efforts should identify, prioritize, and select target analytes presently in commerce for effluent monitoring and surveillance.

  16. Position and enforcement practice of the People's Republic of China's pharmaceutical data exclusivity protection.

    PubMed

    Li, Na; Yu, Xiang; Pecht, Michael

    2016-01-01

    The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People's Republic of China's domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People's Republic of China's Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People's Republic of China's pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People's Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs.

  17. Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

    PubMed

    Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

    2014-09-01

    Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs.

  18. FDA Approvals - Cancer Currents Blog

    Cancer.gov

    Blog posts on cancer drugs and devices approved by the Food and Drug Administration—including summaries of the evidence to support the approvals and what they mean for patients—from NCI Cancer Currents.

  19. 40 CFR 52.1272 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Mississippi § 52.1272 Approval status. With the exceptions set forth in this subpart, the Administrator approves Mississippi's plan for...

  20. Pharmaceuticals: pharmaceutical cost controls--2005. End of Year Issue Brief.

    PubMed

    Seay, Melicia; Varma, Priya

    2005-12-31

    The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization

  1. Basics of Compounding: Clinical Pharmaceutics, Part 1.

    PubMed

    Allen, Loyd V

    2016-01-01

    Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Pharmacy is unique as it contains a knowledge base significantly different from that of physicians, nurses, and other health-related practitioners. The separation of the science and the practice of pharmacy have prevented the complete utilization of pharmaceutical sciences in the clinical environment far too long. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  2. Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

    PubMed

    Banerjee, Tannista; Nayak, Arnab

    2017-01-01

    This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

  3. Pitolisant: First Global Approval.

    PubMed

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  4. Olaparib: first global approval.

    PubMed

    Deeks, Emma D

    2015-02-01

    Olaparib (Lynparza™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by AstraZeneca for the treatment of solid tumours. The primary indication that olaparib is being developed for is BRCA mutation-positive ovarian cancer. A capsule formulation of the drug has received approval for use in this setting in the EU and USA, and a tablet formulation is in global phase III trials (including in the USA, EU, Australia, Brazil, Canada, China, Israel, Japan, Russia and South Korea). In addition, phase III trials in breast, gastric and pancreatic cancer are underway/planned, and phase I/II investigation is being conducted in other malignancies, including prostate cancer, non-small cell lung cancer, Ewing's sarcoma and advanced cancer. This article summarizes the milestones in the development of olaparib leading to this first approval for ovarian cancer.

  5. Cariprazine: First Global Approval.

    PubMed

    McCormack, Paul L

    2015-11-01

    Cariprazine (Vraylar) is an oral atypical antipsychotic originated by Gedeon Richter. It is a potent dopamine D3 and D2 receptor partial agonist, which preferentially binds to the D3 receptor. Cariprazine also has partial agonist activity at serotonin 5-HT1A receptors. In September 2015, cariprazine received its first global approval in the USA for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It is also in development in a variety of countries for the treatment of schizophrenia with predominant negative symptoms (phase III), as adjunctive therapy for major depressive disorder (phase II/III) and for the treatment of bipolar depression (phase II). This article summarizes the milestones in the development of cariprazine leading to this first approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder.

  6. Sarilumab: First Global Approval.

    PubMed

    Scott, Lesley J

    2017-04-01

    Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more biological or non-biological disease-modifying anti-rheumatic drugs. It is under regulatory review for use in rheumatoid arthritis in other countries, including in the EU, USA and Japan. Sarilumab is also under phase II investigation for the treatment of juvenile idiopathic arthritis. This article summarizes the milestones in the development of sarilumab leading to its first global approval for the treatment of rheumatoid arthritis.

  7. Yucca Mountain repository approved

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    At a quiet White House ceremony on 23 July, U.S. President George W. Bush signed into law House Joint Resolution 87, which approves the site at Yucca Mountain, Nevada, for the development of a repository for disposing of high-level radioactive waste and spent nuclear fuel.White House spokesman Ari Fleischer called the signing “an important step forward on the way to a comprehensive policy for dealing with our nation's nuclear waste.”

  8. Quantitative Systems Pharmacology can reduce attrition and improve productivity in pharmaceutical research and development.

    PubMed

    Leil, Tarek A; Bertz, Richard

    2014-01-01

    The empirical hypothesis generation and testing approach to pharmaceutical research and development (R&D), and biomedical research has proven very effective over the last half-century; resulting in tremendous increases productivity and the rates of approval for new drug applications at the Food and Drug Administration (FDA). However, as discovery of new therapeutic approaches for diseases with unmet medical need becomes more challenging, the productivity and efficiency of the traditional approach to drug discovery and development is diminishing. Innovative approaches are needed, such as those offered by Quantitative Systems Pharmacology (QSP) modeling and simulation. This "systems" approach to modeling and simulation can be used to guide the hypothesis generation and testing process in pharmaceutical R&D, in a manner similar to its adoption in other industries in the past. Embedding QSP into the existing processes within pharmaceutical discovery and development will be required in order to realize the full beneficial impact of this innovative approach.

  9. Quantitative Systems Pharmacology can reduce attrition and improve productivity in pharmaceutical research and development

    PubMed Central

    Leil, Tarek A.; Bertz, Richard

    2014-01-01

    The empirical hypothesis generation and testing approach to pharmaceutical research and development (R&D), and biomedical research has proven very effective over the last half-century; resulting in tremendous increases productivity and the rates of approval for new drug applications at the Food and Drug Administration (FDA). However, as discovery of new therapeutic approaches for diseases with unmet medical need becomes more challenging, the productivity and efficiency of the traditional approach to drug discovery and development is diminishing. Innovative approaches are needed, such as those offered by Quantitative Systems Pharmacology (QSP) modeling and simulation. This “systems” approach to modeling and simulation can be used to guide the hypothesis generation and testing process in pharmaceutical R&D, in a manner similar to its adoption in other industries in the past. Embedding QSP into the existing processes within pharmaceutical discovery and development will be required in order to realize the full beneficial impact of this innovative approach. PMID:25426074

  10. Pharmaceutical policies in Canada: another example of federal-provincial discord

    PubMed Central

    Anis, A H

    2000-01-01

    Pharmaceutical policy in Canada is set at both the federal and provincial levels of government. The federal government is responsible for intellectual property rights of manufacturers (patents) and the initial approval and labelling of prescription drugs and for ensuring overall market competitiveness. The provincial government has responsibility and jurisdiction over the funding of all health care services, including pharmaceuticals. Various interactions between the pharmaceutical industry, the federal and provincial governments and consumers have shaped the current landscape for prescription drugs in Canada. One key failing of the system is that the federal government is almost completely insulated from the impact of its policies because, although it regulates drug prices, it does not buy any drugs. In contrast, provincial governments have no jurisdiction over market competitiveness or pricing, yet end up paying for most of the drug expenditures incurred. PMID:10701389

  11. [Changes in the norms governing practices for the manufacture of pharmaceutical products: implications for the MERCOSUR].

    PubMed

    Temprano, G; Prats, S; Bregni, C

    1998-11-01

    It is done a comparative study between the "Recommended rules for drug products manufacturing and inspection", approved in 1975 by the World Health Organization (and still in force in the MERCOSUR); and the standards published in 1992 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report, named "Good Manufacturing Practices for pharmaceutical products". The correspondence between the regulation in force in the MERCOSUR and the Good Manufacturing Practices Inspection Guide for pharmaceutical industry, used by Health Authorities in the Common Market Member States, is analysed. It is noticed a disagreement between the rule in force and the instrument for verifying its fulfillment. The proposal of this article is the adoption by the Common Market Group, of the rules published by the WHO in 1992, and the establishment of an inspection guide which absolute agrees with it.

  12. Veterinary medicines: product update.

    PubMed

    2014-04-05

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues.

  13. Veterinary medicines: product update.

    PubMed

    2014-03-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues.

  14. Veterinary medicines: product update.

    PubMed

    2014-08-02

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues.

  15. Veterinary medicines: product update.

    PubMed

    2014-11-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues.

  16. Veterinary medicines: product update.

    PubMed

    2014-09-06

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK, and on other relevant issues.

  17. Veterinary medicines update.

    PubMed

    2017-03-11

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues.

  18. USDA Gin Lab Updates

    USDA-ARS?s Scientific Manuscript database

    This presentation provides an update to ginning industry stakeholders on current research efforts ongoing at the three USDA ARS ginning laboratories in Lubbock, TX, Stoneville, MS, and Mesilla Park, NM....

  19. ISS Update: Suitport Testing

    NASA Image and Video Library

    ISS Update commentator Lynnette Madison interviews Joel Maganza, Test Director, about thermal vacuum chambers and unmanned and human-testing with the Suitport. Questions? Ask us on Twitter @NASA_Jo...

  20. ACS Updates Environmental Report.

    ERIC Educational Resources Information Center

    Chemical and Engineering News, 1978

    1978-01-01

    Describes a new publication of a report prepared by the American Chemical Society's Committee on Environmental Improvement. This is a new version that updates a 1969 report and contains additional material and expanded recommendations. (GA)

  1. Red Hill Updates

    EPA Pesticide Factsheets

    This and other periodic updates are intended to keep the public informed on major progress being made to protect public health and the environment at the Red Hill Underground Fuel Storage Facility in Hawaii.

  2. Michael Griffin Update

    NASA Image and Video Library

    2005-04-13

    NASA Administrator Michael Griffin delivers remarks during a NASA Update program at NASA Headquarters, Thursday, April 14, 2005, in Washington after being sworn in earlier that morning as NASA's 11th Administrator. Photo Credit: (NASA/Heidi Fancher)

  3. Michael Griffin Update

    NASA Image and Video Library

    2005-04-13

    NASA Administrator Michael Griffin delivers remarks during a NASA Update program at NASA Headquarters, Thursday, April 14, 2005, in Washington after being sworn in earlier that morning as NASA's 11th Administrator. Photo Credit: (NASA/Renee Bouchard)

  4. ISS Update: NEEMO 16

    NASA Image and Video Library

    ISS Update commentator Josh Byerly interviews astronaut Stan Love about the NEEMO 16 mission from Aquarius Base. Questions? Ask us on Twitter @NASA_Johnson and include the hashtag #askStation. For ...

  5. Center Director's Update

    NASA Image and Video Library

    2016-03-01

    In the Space Shuttle Atlantis exhibit facility at the Kennedy Space Center's Visitor Complex, center director Bob Cabana, in the center background, speaks to guests as he updates community leaders on current and future activities at the space center.

  6. Baricitinib: First Global Approval.

    PubMed

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  7. Osimertinib: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC.

  8. Tasimelteon: first global approval.

    PubMed

    Dhillon, Sohita; Clarke, Madeleine

    2014-03-01

    Tasimelteon (HETLIOZ™) is an orally bioavailable agonist of the melatonin MT1 and MT2 receptors that has been approved in the US for the treatment of non-24-hour sleep-wake disorder. It is the first US FDA-approved medication for this orphan indication. Melatonin is thought to play a role in governing the body's natural sleep-wake cycle through physiological processes regulated in the suprachiasmatic nucleus of the hypothalamus. The hormone is secreted by the pineal gland, with onset typically occurring when daylight begins to dim. In healthy, sighted individuals, the endogenous circadian period is a little over 24 hours, but is entrained to the 24-hour day through exposure to environmental cues, such as light and darkness. In the absence of these cues, synchronisation is lost and the circadian rhythm follows the intrinsic non-24-hour clock, resulting in disorders like non-24-hour sleep-wake disorder. Because the rhythm of endogenous melatonin is considered to be a measure of the human circadian phase, the carefully timed administration of melatonin analogues, such as tasimelteon, can potentially promote circadian readjustment. This article summarizes the milestones in the development of tasimelteon leading to this first approval for the treatment of non-24-hour sleep-wake disorder.

  9. Dolutegravir: first global approval.

    PubMed

    Ballantyne, Anita D; Perry, Caroline M

    2013-09-01

    Dolutegravir, an orally administered HIV-1 integrase strand transfer inhibitor (INSTI), is under development by ViiV Healthcare. Like other drugs belonging in the INSTI class of antiretroviral agents, dolutegravir binds to the integrase site of HIV-1 and blocks the strand transfer integration step, thereby preventing the replication of HIV-1. Dolutegravir is being developed as an unboosted once-daily therapy for use in combination with other antiretroviral agents for the treatment of both treatment-naïve and treatment-experienced patients with HIV-1 infection. Dolutegravir has been approved in the USA for the treatment of HIV-1 infection in combination with other antiretroviral agents and has been filed for approval in the EU and Canada. Phase III development is underway in North America, Europe, South Africa, South America, Australia and Taiwan. This article summarizes the milestones in the development of dolutegravir leading to this first approval for the treatment of HIV-1 infection in both therapy-naïve and -experienced patients.

  10. Ipilimumab: first global approval.

    PubMed

    Cameron, Fiona; Whiteside, Glenn; Perry, Caroline

    2011-05-28

    Ipilimumab (Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma. In the EU, it is awaiting approval as second-line therapy for melanoma. Ipilimumab blocks the effects of the negative T-cell regulator CTLA-4, which may in turn augment T-cell responses to tumour cells. Preclinical studies have indicated that antibody blocking of CTLA-4 can lead to potent immune responses. Ipilimumab is also in development as first- and second-line therapy for prostate cancer where it has progressed to phase III clinical trials worldwide, and it is in phase II development for non-small cell lung cancer. Ipilimumab was originated by the University of California, Berkeley, in the US and subsequently licensed to Medarex, which was later acquired by Bristol-Myers Squibb. This article summarizes the milestones in the development of intravenous ipilimumab leading to this first approval. This profile has been extracted from Wolters Kluwer's R&D Insight drug pipeline database. R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  11. Vortioxetine: first global approval.

    PubMed

    Gibb, Andrew; Deeks, Emma D

    2014-01-01

    Vortioxetine is an orally administered small molecule developed by Lundbeck A/S for the once-daily treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Vortioxetine received its first global approval for MDD in the USA in September 2013 and regulatory approval for its use in this indication in the EU (where it has received a positive opinion) and Canada is awaited. The drug is a bis-aryl-sulphanyl amine compound that combines serotonin (5-HT) reuptake inhibition with other characteristics, including receptor activity modulation. In vitro studies indicate that vortioxetine is an inhibitor of the 5-HT transporter and is a 5-HT(1D), 5-HT₃ and 5-HT₇ receptor antagonist, a 5-HT(1A) receptor agonist and a 5-HT(1B) receptor partial agonist. Animal and in vitro studies indicate that several neurotransmitter systems may be impacted by vortioxetine, with the drug enhancing levels of 5-HT, noradrenaline, dopamine, acetylcholine and histamine in certain areas of the brain, as well as modulating γ-aminobutyric acid and glutamate neurotransmission. Phase III trials of vortioxetine in both MDD and GAD have been conducted worldwide. This article summarizes the milestones in the development of vortioxetine leading to this first approval for MDD.

  12. Biosafe nanoscale pharmaceutical adjuvant materials.

    PubMed

    Jin, Shubin; Li, Shengliang; Wang, Chongxi; Liu, Juan; Yang, Xiaolong; Wang, Paul C; Zhang, Xin; Liang, Xing-Jie

    2014-09-01

    Thanks to developments in the field of nanotechnology over the past decades, more and more biosafe nanoscale materials have become available for use as pharmaceutical adjuvants in medical research. Nanomaterials possess unique properties which could be employed to develop drug carriers with longer circulation time, higher loading capacity, better stability in physiological conditions, controlled drug release, and targeted drug delivery. In this review article, we will review recent progress in the application of representative organic, inorganic and hybrid biosafe nanoscale materials in pharmaceutical research, especially focusing on nanomaterial-based novel drug delivery systems. In addition, we briefly discuss the advantages and notable functions that make these nanomaterials suitable for the design of new medicines; the biosafety of each material discussed in this article is also highlighted to provide a comprehensive understanding of their adjuvant attributes.

  13. Ethics and the pharmaceutical industry.

    PubMed

    Green, Stephen

    2008-06-01

    Relationships between the pharmaceutical industry and the medical profession enhance the potential for physicians to become involved in conflicts of interest. Whether or not these rise to a level that violates standards of medical ethics depends on the degree to which they detract from the quality of health care and its cost, the objectivity of research, and the profession's integrity. This paper explores those issues from two perspectives--the micro-level of the medical profession and the macro-level of society. Practices and policies that affect varied aspects of the interaction between the pharmaceutical industry and the medical profession--such as education, research and marketing--are discussed. The reader is asked to reflect on the ethics of issues raised; the author offers suggestions for mitigating conflicts of interest and, in turn, the potential for unethical medical care.

  14. Biosafe Nanoscale Pharmaceutical Adjuvant Materials

    PubMed Central

    Jin, Shubin; Li, Shengliang; Wang, Chongxi; Liu, Juan; Yang, Xiaolong; Wang, Paul C.; Zhang, Xin; Liang, Xing-Jie

    2014-01-01

    Thanks to developments in the field of nanotechnology over the past decades, more and more biosafe nanoscale materials have become available for use as pharmaceutical adjuvants in medical research. Nanomaterials possess unique properties which could be employed to develop drug carriers with longer circulation time, higher loading capacity, better stability in physiological conditions, controlled drug release, and targeted drug delivery. In this review article, we will review recent progress in the application of representative organic, inorganic and hybrid biosafe nanoscale materials in pharmaceutical research, especially focusing on nanomaterial-based novel drug delivery systems. In addition, we briefly discuss the advantages and notable functions that make these nanomaterials suitable for the design of new medicines; the biosafety of each material discussed in this article is also highlighted to provide a comprehensive understanding of their adjuvant attributes. PMID:25429253

  15. Public policy and pharmaceutical innovation.

    PubMed

    Grabowski, H G

    1982-09-01

    Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures.

  16. Public Policy and Pharmaceutical Innovation

    PubMed Central

    Grabowski, Henry G.

    1982-01-01

    Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures. PMID:10309721

  17. Economic analysis and pharmaceutical policy.

    PubMed

    Rovira, J

    1995-10-01

    Economic evaluation, a comparative analysis of alternative actions in terms of costs and consequences, allows rational decisions to be made concerning the deployment of resources (people, time, equipment, facilities and knowledge). Pharmaceutical policy reflects the various objectives of the many social groups, some of which are conflicting. While new methodologies for evaluation of health care programmes still need to gain wider acceptance, resource limitations for both care providers and decision makers make economic analysis an increasingly important tool.

  18. Methods for the comparative evaluation of pharmaceuticals.

    PubMed

    Zentner, Annette; Velasco-Garrido, Marcial; Busse, Reinhard

    2005-11-15

    of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings. The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation. Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy. If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use. It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions). As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom) and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible. In the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and economic characteristics to daily treatment routine. However

  19. [E-commerce of pharmaceuticals].

    PubMed

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

  20. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    While the point-source emissions of pollutants from manufacturing waste streams have long been monitored and subject to controls, the environmental impact of the public's (i.e., the individual's) activities regarding the use of chemicals is more difficult to assess. Of particular question is the widespread release to sewage and surface/ground waters of pharmaceuticals and personal care products after their ingestion, external application, or disposal. Certain pharmaceutically active compounds (e.g., caffeine, nicotine, and aspirin) have been known for over 20 years to enter the environment by a variety of routes - primarily via treated and untreated sewage effluent. A larger picture, however, has emerged only more recently, where it is evident that numerous personal care products (such as fragrances and sunscreens) and drugs from a wide spectrum of therapeutic classes can occur in the environment and drinking water (albeit at very low concentrations), especially in natural waters receiving sewage. Nearly all ecological monitoring studies for pharmaceuticals and personal care products (informally referred to as

  1. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovská, Kateřina; Křesálek, Vojtěch

    2015-10-01

    Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.

  2. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

    Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

  3. Health risks of counterfeit pharmaceuticals.

    PubMed

    ten Ham, Martijn

    2003-01-01

    Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

  4. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

    Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

  5. Pharmaceutical study of Lauha Bhasma.

    PubMed

    Singh, Neetu; Reddy, K R C

    2010-07-01

    In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like "pakwa jambu phala varna," varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta.

  6. Understanding pharmaceutical quality by design.

    PubMed

    Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet

    2014-07-01

    This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

  7. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta

  8. Issues in pharmaceutical development of thymosin alpha1 from preclinical studies through marketing.

    PubMed

    Tuthill, Cynthia

    2007-09-01

    SciClone Pharmaceuticals licensed the commercial and patent rights to thymosin alpha1, for geographical regions of the world excluding the United States and Europe, in the early 1990s. With this license, SciClone embarked on global drug development, and the issues encountered for thymosin alpha1 are reflective of the roller coaster of modern approval of pharmaceuticals. Most of the required toxicology studies had been completed prior to licensure, but some newer studies had to be conducted to obtain approvals in certain countries. The recent development of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH) guidelines allows for a clearer definition of the required battery of toxicology studies, although some countries still have not adopted these guidelines, and the local regulations have had to be understood and followed. Other hurdles include the complications that manufacturing requirements can differ between countries, and certain countries require local clinical experience trials in addition to SciClone's cumulative clinical data. A further obstacle was the pleiotropic nature of the mechanism of action of thymosin alpha1, with the resulting difficulty in the unraveling of its pharmacologic effects. With close attention to these regulatory details, SciClone has obtained approvals in more than 30 countries and has successfully begun commercial sales.

  9. Student Evaluation of Online Pharmaceutical Compounding Videos

    PubMed Central

    Park, Hanna L.

    2016-01-01

    Objective. To describe pharmacy students’ views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene’s) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1–2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy. PMID:27073283

  10. Student Evaluation of Online Pharmaceutical Compounding Videos.

    PubMed

    Park, Hanna L; Shrewsbury, Robert P

    2016-03-25

    Objective. To describe pharmacy students' views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene's) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1-2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy.

  11. Restructuring the Production of Medicines: An Investigation on the Pharmaceutical Sector in China and the Role of Mergers and Acquisitions.

    PubMed

    Barbieri, Elisa; Huang, Manli; Pi, Shenglei; Tassinari, Mattia

    2017-10-05

    In places like China, an ageing population coupled with changes in living standards and increases in disposable income, imply a shift of the demand for health-related goods and services which is likely to affect the whole organization of the industries that supply such goods and services at the global level. One of the industries most likely to be affected is the pharmaceutical sector. In the early 2000s China was already the second largest global producer of pharmaceutical ingredients. The pharmaceutical sector has become one of the most important industries promoted by the Chinese government and Five-Year Plan of China's Strategic Emerging Sectors, mergers and acquisition (M&A) activity has been the key strategy to restructure the sector and increase its competitiveness. This paper firstly provides an updated picture of the evolution of M&As in the pharmaceutical sector, compared to other sectors, in China in the period 2005-2013. Secondly, we develop a composite indicator to measure the industrial performance of all Chinese industrial sectors over time, which allows us to assess the performance of the pharmaceutical industry compared to that of other sectors of the Chinese economy. Finally, we develop and estimate an empirical model that tests the relationship between the number of M&A in a sector and its performance, with a particular focus on the pharmaceutical case. The results offer some initial evidence of positive effects from the process of restructuring of the pharmaceutical sector in China.

  12. Update on medicines for smoking cessation

    PubMed Central

    McDonough, Mike

    2015-01-01

    Summary Persistent cigarette smokers usually have a nicotine addiction. This addiction has a chronic relapsing and sometimes remitting course and may persist lifelong. Remission can be facilitated by the use of medication as part of a comprehensive management strategy tailored to the individual patient. Nicotine replacement therapy is a first-line drug treatment. It is available in many formulations. Varenicline is also a first-line drug treatment. It should be started before the patient stops smoking. Bupropion is a second-line therapy. It may be associated with an increased risk of seizures and drug interactions. While there is some evidence that electronic cigarettes might facilitate smoking cessation, quit rates are not yet comparable with those of the drugs approved on the Pharmaceutical Benefits Scheme. PMID:26648633

  13. Emergency contraception update: a Canadian perspective.

    PubMed

    Leung, V W Y; Soon, J A; Levine, M

    2008-01-01

    Barriers to hormonal emergency contraceptive (EC) access in Canada and the United States led professional and lay groups to lobby for levonorgestrel (LNG) (PLAN B, Barr Pharmaceuticals, Pomona, New York) to be made available over-the-counter. In December 2000, British Columbia, Canada, granted EC prescriptive authority to pharmacists, followed by Quebec in December 2001 and Saskatchewan in September 2003. In April 2005, Health Canada placed LNG on non-prescription, behind-the-pharmacy-counter status with no age restriction. After much controversy, in August 2006, the Food and Drug Administration (FDA) approved over-the-counter access to LNG by adults in the United States. Results of our experience in Canada and recent information regarding mechanisms of action, effectiveness, adverse effects, and the effect of increased availability on reproductive health outcomes are presented here to help inform clinical practice.

  14. Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia

    PubMed Central

    2010-01-01

    Background Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Methods Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Results Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications

  15. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

    PubMed

    2015-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

  16. House approves Competitiveness Bill

    NASA Astrophysics Data System (ADS)

    Bush, Susan

    After nearly 3 weeks of debate, the House approved the National Competitiveness Act of 1993 (HR820) on May 19. Subtitle B of the bill lays out specific roles for the National Science Foundation in supporting expansion of the agency's activities to include manufacturing technology development, worker training partnerships, and total quality management programs.Many geoscientists believe that this mandate runs contradictory to NSF's established mission of supporting basic research (Eos, April 13, 1993) and are concerned that basic research funds might be diverted to support manufacturing within the agency.

  17. 78 FR 11265 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... collected for an aircraft when it was first registered. The updated registration database will then be used... directives to aircraft owners. Law enforcement and national security agencies will use the database to... of Renewed Approval of Information Collection: Aircraft Registration Renewal AGENCY: Federal Aviation...

  18. 78 FR 57267 - Approval and Promulgation of Implementation Plans; State of Missouri; Conformity of General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; State of Missouri; Conformity of... general conformity rule in its entirety to bring in into compliance with the Federal general conformity rule which was updated in the Federal Register on April 5, 2010. General conformity...

  19. 78 FR 57335 - Approval and Promulgation of Implementation Plans; State of Missouri; Conformity of General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; State of Missouri; Conformity of... conformity rule in its entirety to bring it into compliance with the Federal general conformity rule which was updated in the Federal Register on April 5, 2010. General conformity regulations prohibit...

  20. 31 CFR 33.116 - Federal public notice and approval process.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance: Treasury 1 2013-07-01 2013-07-01 false Federal public notice and approval process. 33.116 Section 33.116 Money and Finance: Treasury Office of the Secretary of the Treasury WAIVERS... Services will make available through its Web site and otherwise, and shall update as appropriate, public...

  1. 77 FR 3531 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-24

    ... Commission is granting approval of the proposed rule change. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4... controls associated with DTC's Receiver Authorized Delivery (``RAD'') function. The RAD function enables... is directed to its account by another Participant before its account is updated. The RAD function...

  2. 78 FR 57213 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-17

    ... construction. Electrical vault. Taxiway H construction. Storm water update. Gulfstream Road/tunnel design..., (601) 664-9893. Public Agency: Niagara Frontier Transportation Authority, Buffalo, New York... Description of Projects Approved for Collection and Use at Buffalo Niagara International Airport (BUF) at a...

  3. 76 FR 12405 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-07

    ... geographical information system/electronic airport layout plan. Design/construct west terminal parking... (radios). Airfield vault replacement. Flight information display system. Airport master plan update...-scheduled/ on-demand operators filing FAA Form 1800-31. Determination: Approved. Based on information...

  4. 29 CFR 1956.60 - Description of the plan as initially approved.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... identical to OSHA occupational safety and health standards promulgated as of December 7, 1998, with... commitment to bring those two (2) standards into conformance with OSHA requirements and to update all standards within one year after plan approval. The State plan also provides that future OSHA standards and...

  5. 29 CFR 1956.60 - Description of the plan as initially approved.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... identical to OSHA occupational safety and health standards promulgated as of December 7, 1998, with... commitment to bring those two (2) standards into conformance with OSHA requirements and to update all standards within one year after plan approval. The State plan also provides that future OSHA standards and...

  6. 29 CFR 1956.60 - Description of the plan as initially approved.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... identical to OSHA occupational safety and health standards promulgated as of December 7, 1998, with... commitment to bring those two (2) standards into conformance with OSHA requirements and to update all standards within one year after plan approval. The State plan also provides that future OSHA standards and...

  7. 78 FR 19991 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Motor Vehicle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    .... Effective Date EPA finds that there is good cause for this approval to become effective on the date of... for good cause found and published with the rule.'' Ensuring that the updated MVEBs are available as... in hard copy form. Publicly available docket materials are available either electronically through...

  8. 76 FR 60961 - Approval of Noise Compatibility Program; Kissimmee Gateway Airport, Kissimmee, FL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... available on-line at: http://www.faa.gov/airports_airtraffic/airports/environmental/airport_noise/part_150... Federal Aviation Administration Approval of Noise Compatibility Program; Kissimmee Gateway Airport... Gateway Airport Noise Compatibility Program Update. Some of the recommendations of the Program...

  9. Introduction: Institutional corruption and the pharmaceutical policy.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations.

  10. China: current trends in pharmaceutical drug discovery.

    PubMed

    Luo, Ying

    2008-04-01

    Pharmaceutical discovery and development is expensive and highly risky, even for multinational corporations. As a developing country with limited financial resources, China has been seeking the most cost-effective means to reach the same level of innovation and productivity as Western countries in the pharmaceutical industry sector. After more than 50 years of building up talent and experience, the time for China to become a powerhouse in pharmaceutical innovation is finally approaching. Returnee scientists to China are one of the reasons for the wave of new discovery and commercialization occurring within the country. The consolidation of local Chinese pharmaceutical companies and foreign investment is also providing an agreeable environment for the evolution of a new generation of biotechnology. The opportunity for pharmaceutical innovation is also being expedited by the entry of multinational companies into the Chinese pharmaceutical market, and by the outsourcing of research from these companies to China.

  11. Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.

    PubMed

    Inokuma, Yasuko

    2017-06-01

    Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result. Through the amendment, regenerative medicine is defined as a new category and is covered by the Relief Service under the amended Pharmaceutical Affairs Act, called the 'Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics' (PMD Act). This amendment allows the use of Relief Service data for pharmacovigilance activities, making the Relief Service the third adverse drug reaction reporting route in addition to the existing reporting routes from marketing authorization holders and healthcare providers. For optimum incorporation and use of this Relief Service data, earlier access should be allowed even before the reports from the Pharmaceuticals and Medical Devices Agency to the Ministry of Health, Labour and Welfare are finalized, which is mandatory under the current PMD Act.

  12. Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.

    PubMed

    Paumgartten, Francisco José Roma

    2016-12-22

    In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

  13. Lesinurad: First Global Approval.

    PubMed

    Hoy, Sheridan M

    2016-03-01

    Lesinurad (ZURAMPIC(®)) is an oral urate-anion exchanger transporter 1 (URAT1) inhibitor developed by Ardea Biosciences (a subsidiary of AstraZeneca) for the treatment of hyperuricaemia associated with gout. It reduces serum uric acid (sUA) levels by inhibiting the function of the transporter proteins (URAT1 and organic anion transporter 4) involved in uric acid reabsorption in the kidney. In December 2015, lesinurad was approved in the USA as combination therapy with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved sUA target levels with a xanthine oxidase inhibitor alone. Lesinurad has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for this indication and is in phase III development as a combination therapy in several other countries. This article summarizes the milestones in the development of lesinurad leading to this first approval for hyperuricaemia associated with gout.

  14. Safinamide: first global approval.

    PubMed

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  15. Niraparib: First Global Approval.

    PubMed

    Scott, Lesley J

    2017-06-01

    Oral niraparib, a highly-selective, potent poly(ADP-ribose) polymerase (PARP)-1 and PARP-2 inhibitor, is approved in the USA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also under regulatory review in the EU for use in maintenance treatment in patients with platinum-sensitive, recurrent epithelial ovarian cancer who are in response to platinum-based chemotherapy. In the multinational, phase 3 NOVA trial in adult patients with platinum-sensitive, recurrent ovarian cancer, niraparib significantly prolonged median progression-free survival, irrespective of the presence or absence of a germline BRCA (gBRCA) mutation and irrespective of the presence or absence of homologous recombinant deficiency. Niraparib is also in development for use in other solid tumours, including breast and prostate cancer. This article summarizes the milestones in the development of niraparib leading to its first global approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

  16. Lenvatinib: first global approval.

    PubMed

    Scott, Lesley J

    2015-04-01

    Lenvatinib (Lenvima™) is a multitargeted receptor kinase inhibitor that inhibits the kinase activities of vascular endothelial-derived growth factor receptors 1, 2 and 3, fibroblast growth factor receptors 1, 2, 3 and 4, platelet-derived growth factor receptor α, RET and KIT. In addition to their role in normal cellular function, these kinases have been implicated in pathogenic angiogenesis, tumour growth and cancer progression. Lenvatinib is being developed by Eisai Co. Ltd for the treatment of solid tumours, primarily for differentiated thyroid cancer, and other malignancies. A capsule formulation of the drug has received approval in the USA for use in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvatinib is in pre-registration for this indication in the EU, Australia, Brazil, Canada, Japan, South Korea, Russia, Singapore and Switzerland, and is in phase 3 development in Argentina, Chile and Thailand. Lenvatinib has orphan designation in the EU and Japan for use in differentiated thyroid cancer. In addition, an ongoing global, phase 3 trial is evaluating the use of lenvatinib as first-line treatment in unresectable hepatocellular carcinoma. This article summarizes the milestones in the development of lenvatinib leading to this first approval in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

  17. Obesity Epidemic: Pharmaceutical Weight Loss.

    PubMed

    Curry, Stephanie A

    2017-03-01

    Obesity is a chronic disease universally defined as an excess of adipose tissue resulting in body mass index (BMI) > 30.0 kg/m2. Over the past few years, the concept of prevention has gained increased awareness, thus leading to the development of additional pharmaceutical options for the treatment of obesity since 2012. Treating obesity revolves around an individualized, multi-disciplinary approach with additional focus on a healthy and supportive lifestyle to maintain the weight loss. [Full article available at http://rimed.org/rimedicaljournal-2017-03.asp].

  18. Kaolinite in pharmaceutics and biomedicine.

    PubMed

    Awad, Mahmoud E; López-Galindo, Alberto; Setti, Massimo; El-Rahmany, Mahmoud M; Iborra, César Viseras

    2017-09-22

    Kaolinite Al2Si2O5(OH)4 is an abundant and inexpensive geomaterial regarded as one of the most common clay minerals in the earth's crust and the most widespread phase among the other kaolin polymorphs (halloysite, dickite and nacrite). Structurally, it is a hydrous aluminum phyllosilicate member belonging to the dioctahedral 1:1 kaolin mineral group. The particle size of the pseudohexagonal kaolinite platelets is normally <2μm (if compared to a human red blood cell of a typical diameter 6.2-8.2μm or to a virus particle of about 50nm diameter). The kaolinite platelets, either stacked together with a common booklet-like shape in a highly ordered structure (well crystallized) or disordered structure (poorly crystallized), consist of layers considered as a strong dipole of hydrophobic siloxane surface dominated by negative charges, and the other hydrophilic aluminol surface carries positive charges. Kaolinite has been used in many pharmaceutical applications as excipient or active ingredient, because it exhibits excellent physical, chemical and surface physicochemical properties. In addition to their classical pharmaceutical uses, kaolinite and its derivatives have been recently considered as a promising material in many biomedical innovation areas such as drug, protein and gene delivery based on the high interaction capacities with organic and biochemical molecules, bioadhesion and cellular uptake. Pharmaceutical kaolin grades are considerably demanded for usage as excipient in formulations of solid and semi-solid dosage forms. The most important functionalities of kaolin used as excipient are reported as diluent, binder, disintegrant, pelletizing and granulating, amorphizing, particle film coating, emulsifying and suspending agent. Because of its uninjured bioactivity, kaolinite has been also used as active agent for treatment of some common diseases. It can be topically administered as hemostatic agent, dermatological protector, anti-inflammatory agent and in

  19. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

    EPA Science Inventory

    Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

  20. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

    EPA Science Inventory

    Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

  1. Update on validation of microbiological methods by AOAC International.

    PubMed

    Andrews, W H

    1994-01-01

    An update is presented of the microbiological methods validated by AOAC since 1983. A sequential listing of the microbiological methods adopted first action between 1939 and 1993 gives the permanent new numbers of each, as introduced in Official Methods of Analysis, 15th Edition. Consideration is given to the expanded applicability of approved methods with respect to food matrix; the predominance of methods for the detection, identification, and serological testing of Salmonella spp.; and the procedures for coliforms and Escherichia coli, which were most frequently approved between 1973 and 1993. The substantial increase in validation of test kits is discussed, and categories of methods for the modification of test kits already approved are defined.

  2. BI-RADS update.

    PubMed

    Mercado, Cecilia L

    2014-05-01

    The updated American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS) has been newly released. This article summarizes the changes and updates that have been made to BI-RADS. The goal of the revised edition continues to be the same: to improve clarification in image interpretation, maintain reporting standardization, and simplify the monitoring of outcomes. The new BI-RADS also introduces new terminology to provide a more universal lexicon across all 3 imaging modalities. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Pharmacy residents' attitudes toward pharmaceutical industry promotion.

    PubMed

    Ashker, Sumer; Burkiewicz, Jill S

    2007-08-15

    The attitudes of pharmacy residents toward pharmaceutical industry promotion and the perceived effects of such promotion on the knowledge and professional practice of the residents were studied. A questionnaire study of current postgraduate year 1 and postgraduate year 2 pharmacy residents was conducted. Questions were adapted from instruments used in studies of medical student or physician attitudes regarding the pharmaceutical industry. The questionnaire requested demographic information about the resident, information regarding the resident's exposure to specific types of pharmaceutical company-related activities, and the resident's perception of whether the residency program or department had policies or guidelines regarding interactions with the pharmaceutical industry. Questions investigated the attitudes toward pharmaceutical industry promotion and the perceived influence of pharmaceutical industry promotion on the professional knowledge and behavior of the residents. Responses were received from 496 pharmacy residents. Nearly all (89%) residents agreed that pharmaceutical company-sponsored educational events enhance knowledge. Almost half (43%) of the respondents reported that information from educational events influences therapeutic recommendations. One quarter (26%) of the pharmacy residents indicated prior training regarding pharmacist-industry interactions, and most (60%) residents indicated that their institution's residencies or departments have policies regarding interactions with the pharmaceutical industry. Most surveyed pharmacy residents believed that educational events sponsored by pharmaceutical companies enhance knowledge. Respondents whose institutions had policies or who had received training about such events were less likely than other respondents to perceive an influence of the events on their knowledge and behavior.

  4. Pharmaceuticals and Controlled Substances and Demolition

    EPA Pesticide Factsheets

    Pharmaceuticals and controlled substances found during residential demolition, such as prescription medications or illegal drugs, may require special treatment for disposal or recycling before demolition.

  5. Pharmaceutical Cocrystals and Their Physicochemical Properties

    PubMed Central

    2009-01-01

    Over the last 20 years, the number of publications outlining the advances in design strategies, growing techniques, and characterization of cocrystals has continued to increase significantly within the crystal engineering field. However, only within the last decade have cocrystals found their place in pharmaceuticals, primarily due to their ability to alter physicochemical properties without compromising the structural integrity of the active pharmaceutical ingredient (API) and thus, possibly, the bioactivity. This review article will highlight and discuss the advances made over the last 10 years pertaining to physical and chemical property improvements through pharmaceutical cocrystalline materials and, hopefully, draw closer the fields of crystal engineering and pharmaceutical sciences. PMID:19503732

  6. Agenda for an anthropology of pharmaceutical practice.

    PubMed

    Nichter, M; Vuckovic, N

    1994-12-01

    Over the last two decades, patterns of pharmaceutical-related behavior and the cultural interpretation of medicines have been examined by anthropologists in several cultural settings. In this paper the authors identify additional issues warranting study so as to broaden the scope of pharmaceutical anthropology, utilizing as a unifying focus the examination of pharmaceutical use in the context of social transformation. Ten interactive themes are presented which bridge micro-level and macro-level investigations of pharmaceutical use. The discussion moves from the discourse on 'rational drug use' to the rationales which underscore drug prescription, manufacture, and demand.

  7. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2014 AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  8. The productivity crisis in pharmaceutical R&D.

    PubMed

    Pammolli, Fabio; Magazzini, Laura; Riccaboni, Massimo

    2011-06-01

    Advances in the understanding of the molecular basis of diseases have expanded the number of plausible therapeutic targets for the development of innovative agents in recent decades. However, although investment in pharmaceutical research and development (R&D) has increased substantially in this time, the lack of a corresponding increase in the output in terms of new drugs being approved indicates that therapeutic innovation has become more challenging. Here, using a large database that contains information on R&D projects for more than 28,000 compounds investigated since 1990, we examine the decline of R&D productivity in pharmaceuticals in the past two decades and its determinants. We show that this decline is associated with an increasing concentration of R&D investments in areas in which the risk of failure is high, which correspond to unmet therapeutic needs and unexploited biological mechanisms. We also investigate the potential variations in productivity with regard to the regional location of companies and find that although companies based in the United States and Europe differ in the composition of their R&D portfolios, there is no evidence of any productivity gap.

  9. SLIDE PRESENTATION--PHARMACEUTICALS AS ...

    EPA Pesticide Factsheets

    While pharmaceuticals are ubiquitous trace contaminants in the environment, thetypes, concentrations, and relative abundances of individual residues will vary depending on thegeographic locale and time of year, primarily a reflection of differing and varying prescribing andconsumption practices. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical

  10. ABSTRACT PRESENTATION--PHARMACEUTICALS AS ...

    EPA Pesticide Factsheets

    Pharmaceuticals comprise a large and diverse array of contaminants that can occur in the environmentfrom the combined activities and actions of multitudes of individuals as well as from veterinary andagricultural use. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, interviews for med

  11. Plant cells as pharmaceutical factories.

    PubMed

    Rischer, Heiko; Häkkinen, Suvi T; Ritala, Anneli; Seppänen-Laakso, Tuulikki; Miralpeix, Bruna; Capell, Teresa; Christou, Paul; Oksman-Caldentey, Kirsi-Marja

    2013-01-01

    Molecules derived from plants make up a sizeable proportion of the drugs currently available on the market. These include a number of secondary metabolite compounds the monetary value of which is very high. New pharmaceuticals often originate in nature. Approximately 50% of new drug entities against cancer or microbial infections are derived from plants or micro-organisms. However, these compounds are structurally often too complex to be economically manufactured by chemical synthesis, and frequently isolation from naturally grown or cultivated plants is not a sustainable option. Therefore the biotechnological production of high-value plant secondary metabolites in cultivated cells is potentially an attractive alternative. Compared to microbial systems eukaryotic organisms such as plants are far more complex, and our understanding of the metabolic pathways in plants and their regulation at the systems level has been rather poor until recently. However, metabolic engineering including advanced multigene transformation techniques and state-of-art metabolomics platforms has given us entirely new tools to exploit plants as Green Factories. Single step engineering may be successful on occasion but in complex pathways, intermediate gene interventions most often do not affect the end product accumulation. In this review we discuss recent developments towards elucidation of complex plant biosynthetic pathways and the production of a number of highvalue pharmaceuticals including paclitaxel, tropane, morphine and terpenoid indole alkaloids in plants and cell cultures.

  12. PHARMACEUTICALS IN THE ENVIRONMENT: SOURCES ...

    EPA Pesticide Factsheets

    An issue that began to receive more attention by environmental scientists in the late 1990s was the conveyancy of pharmaceuticals in the environment by way of their use in human and veterinary medical practices and personal care The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, intervi

  13. Selected pharmaceutical excipient prevent isoniazid and rifampicin induced hepatotoxicity.

    PubMed

    Shih, Tung-Yuan; Ho, Shan-Chu; Hsiong, Cheng-Huei; Huang, Tien-Yu; Hu, Oliver Yoa-Pu

    2013-07-01

    The incidence of isoniazid (INH)- and rifampicin (RIF)-induced abnormal liver enzyme activity is 27% but only 19% with INH alone. Cytochrome P450 2E1 (CYP2E1) is thought to contribute to the synergistic effects of RIF and INH. Pharmaceutical excipients are inactive ingredients that are added to a pharmaceutical compound. The purpose of this study was to screen excipients for CYP2E1 inhibition and identify whether the screened excipients prevented INH/RIF-induced hepatotoxicity. Fifty-five known pharmaceutical excipients were screened for CYP2E1 inhibition. The hepatotoxic doses of INH and RIF were 50 and 100 mg/kg/day, respectively. Hepatotoxicity was assessed by the galactose single point (GSP) method (a US Food and Drug Administration (FDA) recommended quantitative liver function test), liver histopathology, malondialdehyde (MDA) assay, and measurement of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity. We chose the CYP2E1-specific substrate chlorzoxazone to assess CYP2E1 activity in animal and human. Mannitol inhibited CYP2E1 activity by 54% in mice with INH/RIF-induced hepatotoxicity (p < 0.005). Serum AST, ALT and GSP levels were significantly increased 3.8- to 7.8-fold in these mice (p < 0.005), and these levels could be lowered by mannitol. Mannitol significantly alleviated the depletion of hepatic glutathione (GSH) and partially reversed the increase in MDA formation in mice treated with INH/RIF (p < 0.005). Mannitol also decreased CYP2E1 activity by 58% in humans (p < 0.005). Furthermore, an antituberculosis (TB) efficacy assay revealed that mannitol did not affect the anti-TB effects of INH/RIF. Mannitol, an FDA-approved excipient, was found to be a CYP2E1 inhibitor. Mannitol may be a useful adjuvant for drugs that induce hepatotoxicity through CYP2E1, such as INH and RIF.

  14. American Foundation for Pharmaceutical Education Survey of Scientific Manpower Needs in the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Fisher, Albert B., Jr.

    1979-01-01

    Those disciplines in the pharmaceutical sciences where critical manpower shortages now exist or will occur are identified by 34 pharmaceutical manufacturers in response to a request by the American Foundation for Pharmaceutical Education, which awarded fellowships in four critical areas. High priority needs are appended. (JMD)

  15. What is missing on their web sites? An evaluation of national and international pharmaceutical companies in Turkey.

    PubMed

    Yegenoglu, Selen; Aslan, Dilek; Acar, Aylin; Calgan, Zeynep

    2005-12-01

    The Turkish Pharmaceutical Manufacturers Association-Ilaç Endüstrisi Isverenler Sendikasi (IEIS) set guidelines for pharmaceutical companies when designing their websites in 2003. The objective of this study is to evaluate whether pharmaceutical company websites comply with these guidelines. The list of all the national and international pharmaceutical companies active in Turkey is obtained from Farmalist Vademecum. We evaluated each site in terms of availability of drug advertisement, mail address, e-mail address, telephone number, fax number, update information, indication of target group, links, references, information, appropriate content for the intended target group, disclaimer stating the given information is only for health care professionals, disclaimer stating the given information cannot replace a health care professional, responsible body for the website design. The search was done throughout February 2005. We used x(2) test and Fisher's exact x(2) tests for statistical analysis. Of the 82 pharmaceutical companies active in Turkey, 51 had a website eligible for evaluation. Of the 51 companies, 34 (66.7%) were national and 17 (33.3%) were international. Eighteen companies had drug advertisement on the home page of their websites (64.7%). Of the total companies majority had mail address (89.2%); telephone number (89.2%); fax number (84.3%); links (66.7%); and appropriate content for the health care professionals (62.7%). The frequency of having update information and a separate pharmacist/physician information part was higher among international pharmaceutical company websites compared to the national ones. These differences were statistically significant (p < 0.05). As a result of the evaluation, the majority of the pharmaceutical companies failed to comply wholly with the guidelines set by IEIS when designing their website on the Internet.

  16. Senate approves energy bill

    NASA Astrophysics Data System (ADS)

    Bush, Susan

    The controversial National Energy Security Act of 1992 (S2166) was approved by the Senate in a 94-4 vote on February 19 after a circuitous route through the chamber. The original energy bill, SI220, was introduced last summer and was blocked from coming to the Senate floor by a filibuster. The new bill is considerably different from the original energy bill.The sponsor of the bill, S. Bennett Johnston (D-La.), and cosponsor Malcolm Wallop (R-Wyo.) agreed to abandon certain controversial components in order to keep the bill moving. The main program dropped is the proposal to open parts of the Arctic National Wildlife Refuge (ANWR) to oil and gas drilling. Environmentalists were opposed to the drilling and were able to block the entire bill last fall, so Johnston agreed to abandon the provision.

  17. Accountability Update, March 2000.

    ERIC Educational Resources Information Center

    Washington State Higher Education Coordinating Board, Olympia.

    This report provides the Washington State legislature, the Governor, and other interested parties with an update on the accountability performance of each of the state's public baccalaureate institutions (Central Washington University, Eastern Washington University, Evergreen State College, Washington State University, Western Washington…

  18. Supreme Court Update

    ERIC Educational Resources Information Center

    Taylor, Kelley R.

    2009-01-01

    "Chief Justice Flubs Oath." "Justice Ginsburg Has Cancer Surgery." At the start of this year, those were the news headlines about the U.S. Supreme Court. But January 2009 also brought news about key education cases--one resolved and two others on the docket--of which school administrators should take particular note. The Supreme Court updates on…

  19. Updating Older Fume Hoods.

    ERIC Educational Resources Information Center

    Saunders, G. Thomas

    1985-01-01

    Provides information on updating older fume hoods. Areas addressed include: (1) adjustment of the hood's back baffle; (2) hood air leakage; (3) light level; (4) hood location in relation to room traffic and room air; and (5) establishing and maintaining hood performance. (JN)

  20. Updated seismic solar model

    NASA Astrophysics Data System (ADS)

    Dziembowski, W. A.; Goode, Philip R.; Pamyatnykh, A. A.; Sienkiewicz, R.

    1995-05-01

    Recently released low-l solar oscillation data from the BISON network are combined with BBSO data to obtain an updated solar seismic model of the Sun's interior. For the core, the solar seismic model from the new data is more consistent with the current standard solar models than our earlier seismic model. An astrophysical solution to the solar neutrino problem fades away.

  1. Updating: Learning versus Supposing

    ERIC Educational Resources Information Center

    Zhao, Jiaying; Crupi, Vincenzo; Tentori, Katya; Fitelson, Branden; Osherson, Daniel

    2012-01-01

    Bayesian orthodoxy posits a tight relationship between conditional probability and updating. Namely, the probability of an event "A" after learning "B" should equal the conditional probability of "A" given "B" prior to learning "B". We examine whether ordinary judgment conforms to the orthodox view. In three experiments we found substantial…

  2. Solar System Montage Updated

    NASA Image and Video Library

    1999-05-03

    This is an updated montage of planetary images taken by spacecraft managed by NASA’s Jet Propulsion Laboratory in Pasadena, CA. Included are from top to bottom images of Mercury, Venus, Earth and Moon, Mars, Jupiter, Saturn, Uranus and Neptune.

  3. Technology Update-87

    SciTech Connect

    Not Available

    1987-12-01

    The five papers in this issue of Technology Update reflect improvements in equipment reliability, inspection techniques, data storage techniques, and production technology - all aimed at reducing process variations. Each paper represents an achievement by our technical staff that allows Mound to make more effective use of our resources. A separate abstract has been prepared for one of the papers.

  4. Update: Biological Nitrogen Fixation.

    ERIC Educational Resources Information Center

    Wiseman, Alan; And Others

    1985-01-01

    Updates knowledge on nitrogen fixation, indicating that investigation of free-living nitrogen-fixing organisms is proving useful in understanding bacterial partners and is expected to lead to development of more effective symbioses. Specific areas considered include biochemistry/genetics, synthesis control, proteins and enzymes, symbiotic systems,…

  5. "Southwest Strategy" update

    Treesearch

    Steve Kluge

    1999-01-01

    The Southwest Strategy is an effort by federal agencies to work with each other, the public, and tribal, state, and local agencies to maintain and restore the cultural, economic, and environmental quality of life in Arizona and New Mexico. This update explains the strategy and its progress to date.

  6. Supreme Court Update

    ERIC Educational Resources Information Center

    Taylor, Kelley R.

    2009-01-01

    "Chief Justice Flubs Oath." "Justice Ginsburg Has Cancer Surgery." At the start of this year, those were the news headlines about the U.S. Supreme Court. But January 2009 also brought news about key education cases--one resolved and two others on the docket--of which school administrators should take particular note. The Supreme Court updates on…

  7. Updating Older Fume Hoods.

    ERIC Educational Resources Information Center

    Saunders, G. Thomas

    1985-01-01

    Provides information on updating older fume hoods. Areas addressed include: (1) adjustment of the hood's back baffle; (2) hood air leakage; (3) light level; (4) hood location in relation to room traffic and room air; and (5) establishing and maintaining hood performance. (JN)

  8. Year 2000 Update.

    ERIC Educational Resources Information Center

    Berg, Frances M.

    1994-01-01

    Presents an update on the Year 2000 objectives for the nation that establish targets in 22 priority areas. The article offers information from a study on exercise by the President's Council on Physical Fitness and Sports, reviews Healthy People 2000 data, and lists Year 2000 physical activity and fitness objectives. (SM)

  9. Constellation Program Update

    NASA Image and Video Library

    2006-06-04

    Jeff Hanley, Constellation Program Manager, right, listens to a question during a NASA Update outlining responsibilities of the NASA centers associated with the Constellation Program for robotic and human Moon and Mars exploration on Wednesday, June 5, 2006, at NASA Headquarters in Washington. Photo Credit: (NASA/Bill Ingalls)

  10. COPPER RESEARCH UPDATE

    EPA Science Inventory

    This presentation provides an update and overview of new research results and remaining research needs with respect to copper corrosion control issues. The topics to be covered include: occurrence of elevated copper release in systems that meet the Action Level; impact of water c...

  11. SEI: An update

    NASA Technical Reports Server (NTRS)

    Peach, Lewis L., Jr.

    1991-01-01

    An update on the Space Exploration Initiative (SEI) is given in viewgraph form. Topics covered include the key prerequisites of human exploration, project planning, Mars and lunar explorations, supporting technologies, near-term strategies for SEI, human support elements, and Space Station Freedom SEI accommodations.

  12. Center Director's Update

    NASA Image and Video Library

    2016-03-01

    In the Space Shuttle Atlantis exhibit facility at the Kennedy Space Center's Visitor Complex, guests get a close-up look at a plant growth experiment similar to one aboard the International Space Station. This followed a presentation by center director Bob Cabana who updated community leaders on current and future activities at the space center.

  13. Community Update, 1999.

    ERIC Educational Resources Information Center

    Anderson, Julie, Ed.

    1999-01-01

    This document consists of nine issues (covering January through December 1999) of the newsletter "Community Update," containing articles on community and family involvement in education. Article topics include: new programs to help students prepare for college early; Vice President Al Gore announced the first-ever national Hispanic Education…

  14. Constellation Program Update

    NASA Image and Video Library

    2006-06-04

    Dean Acosta, NASA Deputy Assistant Administrator and Press Secretary, left, moderates a NASA Update with NASA Administrator Michael Griffin, second from left, Scott J. Horowitz, NASA Associate Administrator for Exploration Systems and Jeff Hanley, Constellation Program Manager, right, on Wednesday, June 5, 2006, at NASA Headquarters in Washington. Photo Credit: (NASA/Bill Ingalls)

  15. Constellation Program Update

    NASA Image and Video Library

    2006-06-04

    Dean Acosta, NASA Deputy Assistant Administrator and Press Secretary, left, moderates a NASA Update with NASA Administrator Michael Griffin, Scott J. Horowitz, NASA Associate Administrator for Exploration Systems and Jeff Hanley, Constellation Program Manager, right, on Wednesday, June 5, 2006, at NASA Headquarters in Washington. Photo Credit: (NASA/Bill Ingalls)

  16. Constellation Program Update

    NASA Image and Video Library

    2006-06-04

    NASA Administrator Michael Griffin addresses NASA employees and members of the media about the responsibilities of the NASA centers associated with the Constellation Program for robotic and human Moon and Mars exploration during a NASA Update on Wednesday, June 5, 2006, at NASA Headquarters in Washington. Photo Credit: (NASA/Bill Ingalls)

  17. Cultural practices updates

    USDA-ARS?s Scientific Manuscript database

    Cultural practice updates from 2013 included the effects of shredding in spring, residue management, periodic flooding, no-till fertilizer applications, and billet planting on cane tonnage and sugar yield. Shredding, whether high or low, had little impacts in 2013. However, burning following shreddi...

  18. Stereo Science Update

    NASA Image and Video Library

    2009-04-13

    Toni Galvin, principal investigator, Plasma and Superthermal Ion Composition instrument at the University of New Hampshire makes a comment during a Science Update on the STEREO mission at NASA Headquarters in Washington, Tuesday, April 14, 2009. Photo Credit: (NASA/Paul E. Alers)

  19. Updating: Learning versus Supposing

    ERIC Educational Resources Information Center

    Zhao, Jiaying; Crupi, Vincenzo; Tentori, Katya; Fitelson, Branden; Osherson, Daniel

    2012-01-01

    Bayesian orthodoxy posits a tight relationship between conditional probability and updating. Namely, the probability of an event "A" after learning "B" should equal the conditional probability of "A" given "B" prior to learning "B". We examine whether ordinary judgment conforms to the orthodox view. In three experiments we found substantial…

  20. Southern Horticultural Lab Update

    USDA-ARS?s Scientific Manuscript database

    This publication is a new quarterly update for members of the Mississippi Nursery and Landscape Association that is published quarterly in their association newsletter. Two other versions of this newsletter are being submitted to the Louisiana Nursery and Landscape Association (LALNLA) and the Alaba...