Science.gov

Sample records for drug administration circulatory

  1. Drug Enforcement Administration.

    ERIC Educational Resources Information Center

    Department of Justice, Washington, DC.

    This fact sheet contains information relating to drug abuse and abusers; drug traffic legislation; law enforcement; and descriptions of commonly used narcotics, stimulants, depressants, and hallucinogens. Also included is a short but explicit listing of audiovisual aids, an annotated bibliography, and drug identification pictures. The booklet…

  2. DRUG ENFORCEMENT ADMINISTRATION REGISTRATION DATABASE

    EPA Science Inventory

    The Drug Enforcement Administration (DEA), as part of its efforts to control the abuse and misuse of controlled substances and chemicals used in producing some over-the-counter drugs, maintains databases of individuals registered to handle these substances. These databases are av...

  3. [Circulatory responses to adrenaline administration at rest, during physical loading and under anesthesia].

    PubMed

    Palets, L D; Lissova, O I

    1978-06-01

    In chronic experiments, the effects of 0.5 and 2.5 mcg/kg/min adrenaline infusion on central hemodynamics of conscions and anesthetized dogs were studied. Circulatory reactions elicited by blood volume change and running on treadmill were compared before and during adrenaline infusion. In conscions dogs, infusion of 0.5 mcg/kg/min adrenaline increased cardiac output and central venous pressure, decreased systemic vascular resistance and pumping heart capacity, while mean arterial pressure and heart rate were unchanged. It did not change pumping heart capacity in anesthetized dogs. Infusion of 0.5 mcg/kg/min adrenaline did not change the tendency of hemodynamic reactions on hemorrhage and blood transfusion. Exercise during adrenaline infusion resulted in a more cardiac output increase and lesser heart rate increase than without adrenaline. Infusion of 2.5 mcg/kg/min adrenaline induced more significant increase of arterial pressure in conscions dogs than in anesthetized. PMID:680266

  4. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of...

  5. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

  6. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists...

  7. Mass drug administration for malaria

    PubMed Central

    Poirot, Eugenie; Skarbinski, Jacek; Sinclair, David; Kachur, S Patrick; Slutsker, Laurence; Hwang, Jimee

    2013-01-01

    Background Mass drug administration (MDA), defined as the empiric administration of a therapeutic antimalarial regimen to an entire population at the same time, has been a historic component of many malaria control and elimination programmes, but is not currently recommended. With renewed interest in MDA and its role in malaria elimination, this review aims to summarize the findings from existing research studies and program experiences of MDA strategies for reducing malaria burden and transmission. Objectives To assess the impact of antimalarial MDA on population asexual parasitaemia prevalence, parasitaemia incidence, gametocytaemia prevalence, anaemia prevalence, mortality and MDA-associated adverse events. Search methods We searched the Cochrane Infectious Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE+, EMBASE, to February 2013. We also searched CABS Abstracts, LILACS, reference lists, and recent conference proceedings. Selection criteria Cluster-randomized trials and non-randomized controlled studies comparing therapeutic MDA versus placebo or no MDA, and uncontrolled before-and-after studies comparing post-MDA to baseline data were selected. Studies administering intermittent preventive treatment (IPT) to sub-populations (for example, pregnant women, children or infants) were excluded. Data collection and analysis Two authors independently reviewed studies for inclusion, extracted data and assessed risk of bias. Studies were stratified by study design and then subgrouped by endemicity, by co-administration of 8-aminoquinoline plus schizonticide drugs and by plasmodium species. The quality of evidence was assessed using the GRADE approach. Main results Two cluster-randomized trials, eight non-randomized controlled studies and 22 uncontrolled before-and-after studies are included in this review. Twenty-two studies (29 comparisons) compared MDA to placebo or no intervention of which two comparisons were

  8. Drug Abuse Control--Administrative Guidelines.

    ERIC Educational Resources Information Center

    Los Angeles City Schools, CA.

    These guidelines were developed to assist administrators, teachers, and other staff members of the Los Angeles Public Schools in the formulation of an effective program designed to alleviate drug abuse. Staff responsibilities are spelled out. Specific attention is directed to the problems of drug abuse, drug possession and drug selling. The…

  9. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  10. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  11. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  12. [Drug administration through enteral feeding catheters].

    PubMed

    Goñi Viguria, R; Sánchez Sanz, L; Asiain Erro, M; Baztán Indave, A

    2001-01-01

    Because of easiness and accessibility, the oral route of administration is usually the route of choice for medication delivery, as long as the oral drug form is available and the patients' circumstances allow it.In patients admitted to the intensive care unit this route is frequently altered. This provokes difficulties in swallowing and consequently an enteral feeding catheter must be inserted to supply the patient's nutritional requirements. This catheter is also used for the drug administration, which necessitates opening capsules or crushing pills before dilution. When added to drug-nutrient interactions, this process alters the drug's properties and modifies its pharmacokinetic profile, its pharmacological effect and the intensity of side effects. It can also provoke catheter obstruction. The aim of this study was to establish guidelines for drug administration through enteral feeding catheters. We provide a thorough review of the literature, describe oral drug forms, present a protocol for correct drug administration and provide a guide to the most commonly used drugs in our unit. For each of these drugs we include recommendations on administration and possible alternatives. PMID:11459545

  13. 78 FR 69133 - Drug Enforcement Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... International, Inc. By Notice dated May 14, 2013, and published in the Federal Register on May 22, 2013, 78 FR... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug... renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of...

  14. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ..., 2009, (74 FR 4685, January 26, 2009)). In response, the following June FDA launched its Transparency... Register (75 FR 76011, December 7, 2010) online at http://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative:...

  15. Blasé about drug administration.

    PubMed

    Castledine, Sir George

    The trouble with some tasks and procedures in nursing is that you get too used to them, and errors inevitably set in. No other area is as vulnerable to this as drug administration. A recent report from the National Patient Safety Agency highlighted that dozens of patients are killed every year by drug errors. In 2007, the watchdog received reports from NHS staff of 86 000 mistakes in prescribing or administering medicines, compared with 36 335 errors in 2005. In England and Wales, in 96% of cases the incidents caused low or no harm, but 37 patients died during 2007, and another 63 suffered severe harm. PMID:19966750

  16. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  17. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration manuals. 20.107... Administration manuals. (a) Food and Drug Administration administrative staff manuals and instructions that affect a member of the public are available for public disclosure. An index of all such manuals...

  18. Bioadhesion: new possibilities for drug administration?

    PubMed

    Woodley, J

    2001-01-01

    Bioadhesion (and mucoadhesion) is the process whereby synthetic and natural macromolecules adhere to mucosal surfaces in the body. If these materials are then incorporated into pharmaceutical formulations, drug absorption by mucosal cells may be enhanced or the drug released at the site for an extended period of time. For synthetic polymers, such as the chitosans, carbopols and carbomers, the mechanism of bio/mucoadhesion is the result of a number of different physicochemical interactions. Biological bio/mucoadhesives, such as plant lectins, show specific interactions with cell surfaces and mucin and are seen as the 'second generation' bioadhesives. Bioadhesive systems for drug administration via the buccal and nasal cavities are nearing the market; in the case of nasal bioadhesion, bioadhesive microparticles are used. A bioadhesive formulation for drug administration to the vagina is in use. The gastrointestinal tract is proving a more difficult site because of the rapid turnover of mucus, and relatively constant transit time, but intensive research is in progress. Micro- and nano-particles, coated with either bio/mucoadhesive polymers or specific biological bioadhesives, are showing some promise, but will require considerable research and development before reaching the market. PMID:11286325

  19. Intrathecal drug administration in chronic pain syndromes.

    PubMed

    Ver Donck, Ann; Vranken, Jan H; Puylaert, Martine; Hayek, Salim; Mekhail, Nagy; Van Zundert, Jan

    2014-06-01

    Chronic pain may recur after initial response to strong opioids in both patients with cancer and patients without cancer or therapy may be complicated by intolerable side effects. When minimally invasive interventional pain management techniques also fail to provide satisfactory pain relief, continuous intrathecal analgesic administration may be considered. Only 3 products have been officially approved for long-term intrathecal administration: morphine, baclofen, and ziconotide. The efficacy of intrathecal ziconotide for the management of patients with severe chronic refractory noncancer pain was illustrated in 3 placebo-controlled trials. A randomized study showed this treatment option to be effective over a short follow-up period for patients with pain due to cancer or AIDS. The efficacy of intrathecal opioid administration for the management of chronic noncancer pain is mainly derived from prospective and retrospective noncontrolled trials. The effect of intrathecal morphine administration in patients with pain due to cancer was compared with oral or transdermal treatment in a randomized controlled trial, which found better pain control and fewer side effects with intrathecal opioids. Other evidence is derived from cohort studies. Side effects of chronic intrathecal therapy may either be technical (catheter or pump malfunction) or biological (infection). The most troublesome complication is, however, the possibility of granuloma formation at the catheter tip that may induce neurological damage. Given limited studies, the evidence for intrathecal drug administration in patients suffering from cancer-related pain is more compelling than that of chronic noncancer pain. PMID:24118774

  20. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and...

  1. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and...

  2. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and...

  3. Antimalarial mass drug administration: ethical considerations.

    PubMed

    Cheah, Phaik Yeong; White, Nicholas J

    2016-07-01

    Falciparum malaria is a major cause of death and illness in tropical countries, particularly in childhood. In endemic countries, a significant proportion of the community is infected with malaria asymptomatically. One promising way to eliminate malaria is to give the entire population malaria treatment. This is called mass drug administration (MDA) and it raises a number of ethical issues, as possible long-term benefits are uncertain. The effectiveness of MDA is critically dependent on level of participation, so the promised benefits to the community can be annulled by non-participation of a small number of individuals. These potential benefits range a wide spectrum, from the permanent elimination of malaria (success) to a transient reduction in the prevalence of infection and the incidence of illness (failure). The drawbacks of MDA are: inconvenience, potential toxicity, loss of confidence in the elimination campaign, possible drug resistance (though highly unlikely), and the potential for a rebound of malaria illness (if immunity is lost and malaria is reintroduced later). Other ethical issues are related to balancing individual and public health interests, and potentially limiting individual autonomy by making MDA compulsory. PMID:27481834

  4. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration 2011 Parenteral Drug Association/Food and Drug... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug.... Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and...

  5. 78 FR 44574 - Third Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Third Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  6. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  7. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ... HUMAN SERVICES Food and Drug Administration Second Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for representatives of...

  8. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  9. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is not final...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act'' to the Division of...

  10. Animal Models of Social Contact and Drug Self-Administration

    PubMed Central

    Strickland, Justin C.; Smith, Mark A.

    2015-01-01

    Social learning theories of drug abuse propose that individuals imitate drug use behaviors modeled by social peers, and that these behaviors are selectively reinforced and/or punished depending on group norms. Historically, animal models of social influence have focused on distal factors (i.e., those factors outside the drug-taking context) in drug self-administration studies. Recently, several investigators have developed novel models, or significantly modified existing models, to examine the role of proximal factors (i.e., those factors that are immediately present at the time of drug taking) on measures of drug self-administration. Studies using these newer models have revealed several important conclusions regarding the effects of social learning on drug abuse: 1) the presence of a social partner influences drug self-administration, 2) the behavior of a social partner determines whether social contact will increase or decrease drug intake, and 3) social partners can model and imitate specific patterns of drug self-administration. These findings are congruent with those obtained in the human laboratory, providing support for the cross-species generality and validity of these preclinical models. This mini-review describes in detail some of the preclinical animal models used to study social contact and drug self-administration to guide future research on social learning and drug abuse. PMID:26159089

  11. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  12. United States Food and Drug Administration Product Label Changes.

    PubMed

    Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  13. Drugs on the College Campus. A Guide for College Administrators.

    ERIC Educational Resources Information Center

    Nowlis, Helen H.

    This guide to drugs on the college campus provides accurate information to help administrators and other college officials understand and cope with the use of drugs by college students. The problem is defined, and facts about drugs, and the implications and issues occasioned by their use, are presented. Information is also offered in the following…

  14. Mathematical circulatory system model

    NASA Technical Reports Server (NTRS)

    Lakin, William D. (Inventor); Stevens, Scott A. (Inventor)

    2010-01-01

    A system and method of modeling a circulatory system including a regulatory mechanism parameter. In one embodiment, a regulatory mechanism parameter in a lumped parameter model is represented as a logistic function. In another embodiment, the circulatory system model includes a compliant vessel, the model having a parameter representing a change in pressure due to contraction of smooth muscles of a wall of the vessel.

  15. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ..., 2010 (75 FR 22599), FDA announced the availability of the draft guidance. Comments on the draft... the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS... Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.''...

  16. Disinfection practices in intravenous drug administration.

    PubMed

    Helder, Onno K; Kornelisse, René F; Reiss, Irwin K M; Ista, Erwin

    2016-06-01

    The aim of the study was to determine the effectiveness of a feedback intervention on adherence to disinfection procedures during intravenous medication preparation and administration. We found that full adherence to the protocols significantly improved from 7.3% to 21.5% (P < .001) regarding medication preparation and from 7.9% to 15.5% (P = .012) regarding medication administration. However, disinfection practices still need improvement. PMID:26899528

  17. 78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-12

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: To assist the Food and Drug Administration (FDA or Agency) in drafting a strategic...

  18. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing...

  19. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is... relationships among FDA and clinical trial staff, investigators, and institutional review boards...

  20. 21 CFR 20.3 - Certification and authentication of Food and Drug Administration records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Certification and authentication of Food and Drug Administration records. 20.3 Section 20.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug Administration...

  1. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  2. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  3. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  4. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  5. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... listed in 21 CFR 1308.12 in locked compartments under proper temperature controls, permit only authorized... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system...

  6. Difficulties experienced during preparation and administration of oral drugs

    PubMed Central

    Boztepe, Handan; Özdemir, Handan; Karababa, Çiğdem; Yıldız, Özlem

    2014-01-01

    Aim: It was aimed to determine the difficulties experienced by pediatric nurses working in the wards of a university hospital during preparation and administration of drugs and to determine solution recommendations. Material and Methods: One hundred and eight nurses who accepted to participate in the study constituted the sample of the study. Open-ended questions were asked in order to obtain detailed information about the attitudes and views of the participants and face to face interview was used. The problems experienced during preparation and administration of drugs were collected using the data collection form prepared by the investigators. Institution approval, ethics committee approval (HEK12/193) and written informed consent from the nurses who wished to participate in the study were obtained to conduct the study. The data obtained were expressed as figures and percentages. Results: The most commonly reported problems in preparation of drugs included incomplete dissolution of tablets or non-homogeneous distribution in fluids (54.6%) and difficulty in breaking tablets in appropriate doses (45.3%). The most commonly reported problem experienced during administration of drugs was rejection of drugs which tasted bad by babies/children or spitting out the drug (75.9%). In our study, the nurses also mentioned the problems related with drug administration equipment. These problems included fear of injectors (25.9%), escape of the drugs into the respiratory way (15.7%) and lack of appropriate equipment for administering the drugs (7.4%). Conclusions: In our study, it was found that all nurses experienced difficulty in preparing and administering drugs. The problems experienced by the nurses and solution recommendations for these problems were reported to the hospital administration. PMID:26078668

  7. 77 FR 23485 - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-19

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Patient Network Annual Meeting..., Steve.Morin@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. FDA Patient Network This is the inaugural FDA Patient Network Annual Meeting hosted by the FDA Office of Special Health Issues, the Agency's liaison...

  8. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for...

  9. 78 FR 48691 - Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ...The Food and Drug Administration (FDA) is announcing a meeting for patients, caregivers, patient advocates, as well as patient advocate and health professional groups, to provide a primer on drug product development and explore patient involvement in drug development. The meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals,......

  10. 78 FR 13072 - Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA Statistics Forum--2013.'' The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for......

  11. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  12. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATIVE PRACTICES AND PROCEDURES General Administrative Procedures § 10.90 Food and Drug...

  13. Formulation approaches in mitigating toxicity of orally administrated drugs.

    PubMed

    Kadiyala, Irina; Tan, Elijah

    2013-01-01

    This paper provides an overview of current formulation approaches to mitigate toxicity of orally administrated drugs. The formulation approaches are characterized by their intended impact on a drug's pharmacokinetic parameters, pharmacological properties or metabolic pathways. Regulatory opportunities and constraints with focus on U.S. regulations in optimizing a drug's safety or efficacy profile are reviewed. The following formulation approaches are described: (i) pharmacokinetic-modulating and (ii) pharmacodynamic-modulating. In the pharmacokinetic-modulating approach, the pharmacokinetic profile of drug release is modified by, for example, a reduction in peak drug plasma concentration while preserving or improving AUC, thereby potentially reducing toxic effects that may be related to C(max). In the pharmacodynamic-modulating approach, the drug is co-dosed with pharmacologically active or nonpharmacologically active agent or agents intended for mitigation of the drug's toxicity. The pharmacodynamic-modulating approach requires information on the specificity of drug interactions with other compounds and also on metabolic pathways. Examples demonstrating successful formulation work in reducing drug toxicity are provided. The in-depth knowledge of the drug's PK and PD properties combined with a greater understanding of the biology of diseases are necessary for successful drug product formulation leading to optimized in vivo exposure and minimized toxicity. PMID:23317423

  14. The effects of heroin administration and drug cues on impulsivity.

    PubMed

    Jones, Jermaine D; Vadhan, Nehal P; Luba, Rachel R; Comer, Sandra D

    2016-08-01

    Drug addiction is a chronic relapsing disorder characterized by compulsive drug seeking and continued use despite negative consequences. Behavioral impulsivity is a strong predictor of the initiation and maintenance of drug addiction. Preclinical data suggest that heroin may exacerbate impulsive characteristics in an individual but this has yet to be assessed in clinical samples. The current secondary data analysis sought to investigate the effects of heroin on impulsivity along with the effects of exposure to drug cues. Using the current data set, we also tentatively assessed the etiological relationship between impulsivity and heroin abuse. Sixteen heroin-dependent participants were recruited to complete Immediate Memory Task/Delayed Memory Task (IMT/DMT) and GoStop tasks following repeated heroin administration, following acute heroin administration, and following a drug cue exposure session. Four preceding days of active heroin availability, compared to four preceding days of placebo drug availability, increased impulsivity assessed using the IMT and DMT. Presentation of drug cues similarly acted to increase impulsivity assessments on all three tasks. It also appears that heavier users were more susceptible to the influence of drug cues on impulsivity. The present study represents a step toward a more comprehensive understanding of the interaction between opioid abuse and impulsivity. A better understanding of these factors could provide critical insight into the maintenance of heroin use and relapse. PMID:27062912

  15. Food and Drug Administration Drug Approval Process: A History and Overview.

    PubMed

    Williams, Christopher Ty

    2016-03-01

    In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. PMID:26897420

  16. Behavioral economics of drug self-administration and drug abuse policy.

    PubMed Central

    Hursh, S R

    1991-01-01

    The concepts of behavioral economics have proven useful for understanding the environmental control of overall levels of responding for a variety of commodities, including reinforcement by drug self-administration. These general concepts are summarized for application to the analysis of drug-reinforced behavior and proposed as the basis for future applications. This behavioral agenda includes the assessment of abuse liability, the assay of drug-reinforcer interactions, the design of drug abuse interventions, and the formulation of drug abuse public policy. These separate domains of investigation are described as part of an overall strategy for designing model projects to control drug use and testing public policy initiatives. PMID:1955823

  17. Transfusion associated circulatory overload.

    PubMed

    Agnihotri, Naveen; Agnihotri, Ajju

    2014-06-01

    Transfusion associated circulatory overload (TACO) is an established, but grossly under diagnosed and underreported complication of blood transfusion. We present the case of a 46-year-old diabetic and hypertensive patient admitted to our hospital for recurrent episodes of urinary retention. Over initial 3 days of the admission, the patient received multiple units of packed red blood cells (RBC) and fresh frozen plasma, uneventfully. However, the patient developed signs and symptoms suggestive of TACO with only small amount of the 4(th) unit of RBC. The patient had to be shifted to the Intensive Care Unit for further management of this complication. Etiology of TACO is more complex than a mere circulatory overload and is still not completely understood. TACO leads to a prolonged hospital stay and morbidity in the patients developing this complication. TACO thus needs to be suspected in patients at risk for this complication. PMID:24987240

  18. Abdominal Circulatory Interactions.

    PubMed

    Dagar, Gaurav; Taneja, Amit; Nanchal, Rahul S

    2016-04-01

    The abdominal compartment is separated from the thoracic compartment by the diaphragm. Under normal circumstances, a large portion of the venous return crosses the splanchnic and nonsplanchnic abdominal regions before entering the thorax and the right side of the heart. Mechanical ventilation may affect abdominal venous return independent of its interactions at the thoracic level. Changes in pressure in the intra-abdominal compartment may have important implications for organ function within the thorax, particularly if there is a sustained rise in intra-abdominal pressure. It is important to understand the consequences of abdominal pressure changes on respiratory and circulatory physiology. This article elucidates important abdominal-respiratory-circulatory interactions and their clinical effects. PMID:27016167

  19. Influence of Circulation System on Estimation of Absorption and Elimination Constant after per oral Drug Administration: A Reanalysis.

    PubMed

    Rausova, Z; Chrenova, J; Dedik, L

    2013-03-01

    This study aimed to identify the cause of atypical shape of measured concentration-time profile in the peak area by one compartment open model with a lag time (Bateman function with a lag) after single dose oral administration of drug published in "Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Application" by Gabrielsson and Weiner (1997) and two concentration profiles after frequent sampling oral glucose tolerance test. Following the oral administration of 100 μg of substance A to human volunteer, frequent sampling was carried out and concentration-time profiles were obtained. Our hemodynamic circulatory structural model capable of parameters estimation of circulation and gastrointestinal subsystem to explain the plateau within the interval 40-100 min (substance A) and 15-30 min (glucose) of the measured concentration-time profile was developed. The mean residence time, the rate constants of absorption and elimination parameters of our model were calculated. Comparing to the Bateman function, our results demonstrate better approximation of the substance A and glucose concentration-time profile and estimation of absorption rate constant by our structural model. Obtained model results indicate that the atypical shape of measured concentration-time profile of single dose oral administration of drug was probably caused by the gastrointestinal and circulation system with deep compartment. This applies to the substances with high coefficient of absorption. PMID:24019565

  20. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ..., Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, Texas 75204, 214-253-4952, FAX: 214-253-4970, e-mail: David.Arvelo@fda.hhs.gov . Registration: You are encouraged...

  1. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Outsourcing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA), Cincinnati District, in co-sponsorship with Xavier...

  2. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  3. 76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of supplemental grant funds...

  4. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled...

  5. 75 FR 13766 - Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration--Partnering With Industry; Public Conference AGENCY: Food and Drug Administration,...

  6. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... predicate tobacco product. Manufacturers of tobacco products first introduced or delivered for...

  7. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... HUMAN SERVICES Food and Drug Administration Supplemental Funding Under the Food and Drug Administration... Supplemental Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice of intent. SUMMARY: The Food... Medical Policy, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, rm. 6360, Silver...

  8. 76 FR 78931 - Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA) Office of Orphan...

  9. Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

    ERIC Educational Resources Information Center

    Kaufman, Annette R.; Waters, Erika A.; Parascandola, Mark; Augustson, Erik M.; Bansal-Travers, Maansi; Hyland, Andrew; Cummings, K. Michael

    2011-01-01

    Objectives: To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. Methods: A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. Results: Smokers reporting that the FDA does not evaluate cigarettes for…

  10. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  11. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  12. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  13. 21 CFR 10.90 - Food and Drug Administration regulations, recommendations, and agreements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration regulations, recommendations, and agreements. 10.90 Section 10.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a)...

  14. 21 CFR 20.29 - Prohibition on withdrawal of records from Food and Drug Administration files.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Prohibition on withdrawal of records from Food and Drug Administration files. 20.29 Section 20.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... withdrawal of records from Food and Drug Administration files. No person may withdraw records submitted...

  15. 21 CFR 20.2 - Production of records by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... records by Food and Drug Administration employees. (a) Any request for records of the Food and...

  16. 21 CFR 20.30 - Food and Drug Administration Freedom of Information Staff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Freedom of Information Staff. 20.30 Section 20.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.30 Food and Drug Administration Freedom...

  17. 21 CFR 5.1105 - Chief Counsel, Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Chief Counsel, Food and Drug Administration. 5.1105 Section 5.1105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1105 Chief Counsel, Food and Drug Administration. The...

  18. 21 CFR 20.110 - Data and information about Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Data and information about Food and Drug Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Data and information about Food and Drug Administration employees. (a) The name, title, grade,...

  19. 21 CFR 20.110 - Data and information about Food and Drug Administration employees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Data and information about Food and Drug Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Data and information about Food and Drug Administration employees. (a) The name, title, grade,...

  20. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a)...

  1. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a)...

  2. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a)...

  3. 21 CFR 20.28 - Food and Drug Administration determinations of confidentiality.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration determinations of confidentiality. 20.28 Section 20.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.28 Food and Drug Administration determinations of confidentiality. A...

  4. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and...

  5. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  6. 21 CFR 5.1105 - Chief Counsel, Food and Drug Administration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chief Counsel, Food and Drug Administration. 5.1105 Section 5.1105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ORGANIZATION Organization § 5.1105 Chief Counsel, Food and Drug Administration. The...

  7. 76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,'' dated June 2011. The guidance document provides advice to potential......

  8. 75 FR 29561 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ...The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product...

  9. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good... workshop regarding FDA's clinical trial requirements is designed to aid the clinical research professional... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  10. [Animal models of drug dependence using the drug self-administration method].

    PubMed

    Yamamoto, T; Yabuuchi, K; Yamaguchi, T; Nakamichi, M

    2001-01-01

    This paper will review 1) experimental models of drug-seeking behavior and 2) mechanisms underlying the behavior, focusing on cocaine self-administration. After the acquisition of self-administration, vigorous lever-pressing is generally observable after the drug was replaced by saline. This lever-pressing behavior under saline infusion can be considered "drug-seeking behavior". Drug-seeking behavior is reinstated by non-contingent injection of the drug, stress exposure and presentation of drug-associated stimuli even after extinction. This is called a relapse/reinstatement model. Electrophysiological studies showed that the majority of accumbal neurons is tonically inhibited during cocaine self-administration and exhibited phasic increases in firing time-locked to cocaine self-infusion, which might represent the craving state or drive animals to drug-seeking behavior. Voltammetry and microdialysis studies indicated that the timing of drug-seeking responses can be predicted from fluctuations in accumbal extracellular dopamine concentration. Whereas dopamine D2-like agonists reinstated extinguished cocaine-seeking behavior, D1-like agonists prevented the relapse in cocaine-seeking behavior induced by cocaine itself. Given that an AMPA receptor antagonist, but not dopamine antagonist, prevented cocaine-seeking behavior induced by cocaine, glutamate transmission in the nucleus accumbens is thought to be important for expression of craving or drug-seeking behavior. PMID:11233296

  11. [A case of a syndrome resembling PSP after aortic arch replacement under deep hypothermic circulatory arrest].

    PubMed

    Sakiyama, Yusuke; Michizono, Kumiko; Tomari, Shinya; Watanabe, Osamu; Nakahara, Keiichi; Takashima, Hiroshi

    2011-01-01

    A 57-year-old man presented with acute signs and symptoms mimicking PSP (bradykinesia, supranuclear ocular palsy, dysphagia, neck dystonia, and apraxic gait) on the day after a graft replacement surgery, which was performed for aortic arch aneurysm under deep hypothermic circulatory arrest (rectal temperature, 18 degrees C). Dysphagia improved temporarily, but relapsed after a few months. Symptoms did not change during 2 years of antiparkinsonian drug administration. Brain images obtained before the surgery revealed slight atrophy of the midbrain tegmentum and frontal lobes, but the patient was asymptomatic. No findings of cerebral vascular disease and hypoxic encephalopathy were observed on brain images after the surgery. These clinical features resembling PSP might have been caused by deep hypothermia and the patient's predisposition for PSP. This is the first case report in Japan of a syndrome resembling PSP that occurred after aortic arch replacement under deep hypothermic circulatory arrest. PMID:21387699

  12. Challenges Associated with Route of Administration in Neonatal Drug Delivery.

    PubMed

    Linakis, Matthew W; Roberts, Jessica K; Lala, Anita C; Spigarelli, Michael G; Medlicott, Natalie J; Reith, David M; Ward, Robert M; Sherwin, Catherine M T

    2016-02-01

    The administration of drugs to neonates poses significant challenges. The aim of this review was to provide insight into some of these challenges and resolutions that may be encountered with several of the most commonly used routes of administration and dosage forms in neonatal care, including oral, parenteral, transdermal, intrapulmonary, and rectal. Important considerations include fluctuations in stomach pH hours to years after birth, the logistics of setting up an intravenous infusion, the need for reduced particle size for aerosol delivery to the developing neonatal lung, and variation in perirectal venous drainage. Additionally, some of the recently developed technologies for use in neonatal care are described. While the understanding of neonatal drug delivery has advanced over the past several decades, there is still a deficiency of technologies and formulations developed specifically for this population. PMID:26245673

  13. Food and Drug Administration Regulation of in Vitro Diagnostic Devices

    PubMed Central

    Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

    2005-01-01

    The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

  14. Robust model predictive control for optimal continuous drug administration.

    PubMed

    Sopasakis, Pantelis; Patrinos, Panagiotis; Sarimveis, Haralambos

    2014-10-01

    In this paper the model predictive control (MPC) technology is used for tackling the optimal drug administration problem. The important advantage of MPC compared to other control technologies is that it explicitly takes into account the constraints of the system. In particular, for drug treatments of living organisms, MPC can guarantee satisfaction of the minimum toxic concentration (MTC) constraints. A whole-body physiologically-based pharmacokinetic (PBPK) model serves as the dynamic prediction model of the system after it is formulated as a discrete-time state-space model. Only plasma measurements are assumed to be measured on-line. The rest of the states (drug concentrations in other organs and tissues) are estimated in real time by designing an artificial observer. The complete system (observer and MPC controller) is able to drive the drug concentration to the desired levels at the organs of interest, while satisfying the imposed constraints, even in the presence of modelling errors, disturbances and noise. A case study on a PBPK model with 7 compartments, constraints on 5 tissues and a variable drug concentration set-point illustrates the efficiency of the methodology in drug dosing control applications. The proposed methodology is also tested in an uncertain setting and proves successful in presence of modelling errors and inaccurate measurements. PMID:24986530

  15. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  16. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  17. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  18. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  19. 21 CFR 107.200 - Food and Drug Administration-required recall.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Food and Drug Administration-required recall. 107... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA Infant Formula Recalls § 107.200 Food and Drug Administration-required recall. When the Food and Drug Administration determines that...

  20. Expand classical drug administration ways by emerging routes using dendrimer drug delivery systems: a concise overview.

    PubMed

    Mignani, Serge; El Kazzouli, Saïd; Bousmina, Mosto; Majoral, Jean-Pierre

    2013-10-01

    Drugs are introduced into the body by numerous routes such as enteral (oral, sublingual and rectum administration), parenteral (intravascular, intramuscular, subcutaneous and inhalation administration), or topical (skin and mucosal membranes). Each route has specific purposes, advantages and disadvantages. Today, the oral route remains the preferred one for different reasons such as ease and compliance by patients. Several nanoformulated drugs have been already approved by the FDA, such as Abelcet®, Doxil®, Abraxane® or Vivagel®(Starpharma) which is an anionic G4-poly(L-lysine)-type dendrimer showing potent topical vaginal microbicide activity. Numerous biochemical studies, as well as biological and pharmacological applications of both dendrimer based products (dendrimers as therapeutic compounds per se, like Vivagel®) and dendrimers as drug carriers (covalent conjugation or noncovalent encapsulation of drugs) were described. It is widely known that due to their outstanding physical and chemical properties, dendrimers afforded improvement of corresponding carried-drugs as dendrimer-drug complexes or conjugates (versus plain drug) such as biodistribution and pharmacokinetic behaviors. The purpose of this manuscript is to review the recent progresses of dendrimers as nanoscale drug delivery systems for the delivery of drugs using enteral, parenteral and topical routes. In particular, we focus our attention on the emerging and promising routes such as oral, transdermal, ocular and transmucosal routes using dendrimers as delivery systems. PMID:23415951

  1. 28 CFR 0.157 - Federal Bureau of Investigation-Drug Enforcement Administration Senior Executive Service.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Federal Bureau of Investigation-Drug... Administrative Matters § 0.157 Federal Bureau of Investigation—Drug Enforcement Administration Senior Executive... within the Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) to......

  2. 28 CFR 0.157 - Federal Bureau of Investigation-Drug Enforcement Administration Senior Executive Service.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Federal Bureau of Investigation-Drug... Administrative Matters § 0.157 Federal Bureau of Investigation—Drug Enforcement Administration Senior Executive... within the Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) to......

  3. 28 CFR 0.157 - Federal Bureau of Investigation-Drug Enforcement Administration Senior Executive Service.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Federal Bureau of Investigation-Drug... Administrative Matters § 0.157 Federal Bureau of Investigation—Drug Enforcement Administration Senior Executive... within the Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) to......

  4. 28 CFR 0.157 - Federal Bureau of Investigation-Drug Enforcement Administration Senior Executive Service.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Federal Bureau of Investigation-Drug... Administrative Matters § 0.157 Federal Bureau of Investigation—Drug Enforcement Administration Senior Executive... within the Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) to......

  5. 28 CFR 0.157 - Federal Bureau of Investigation-Drug Enforcement Administration Senior Executive Service.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Federal Bureau of Investigation-Drug... Administrative Matters § 0.157 Federal Bureau of Investigation—Drug Enforcement Administration Senior Executive... within the Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) to......

  6. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the Federal Register of January 30, 2013 (78 FR 6332... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration...

  7. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  8. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  9. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  10. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  11. 21 CFR 20.1 - Testimony by Food and Drug Administration employees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., That a written request therefor made by a health, food, or drug officer, prosecuting attorney,...

  12. Real time computation of in vivo drug levels during drug self-administration experiments.

    PubMed

    Tsibulsky, Vladimir L; Norman, Andrew B

    2005-05-01

    A growing body of evidence suggests that the drug concentration in the effect compartment of the body is the major factor regulating self-administration behavior. A novel computer-based protocol was developed to facilitate studies on mechanisms of drug addiction by determining correlations between drug levels and behavior during multiple drug injections and infusions. The core of the system is a user's program written in Medstate Notation language (Med-Associates, Inc.), which runs the self-administration session (with MED-PC software and hardware, Med-Associates, Inc.) and calculates the levels of infused and/or injected drugs in real time during the session. From the comparison of classical exponential and simple linear models of first-order kinetics, it is concluded that exponential solutions for the appropriate differential equations may be replaced with linear equations if the cycle of computation is much shorter than the shortest half-life for the drug. The choice between particular computation equations depends on assumptions about the pharmacokinetics of the particular drug: (i) one-, two- or three-compartment model, (ii) zero-, first- or second-order process of elimination, (iii) the constants of distribution and elimination half-lives of the drug are known or can be reasonably assumed, (iv) dependence of the constants on the drug level, and (v) temporal stability of all parameters during the session. This method of drug level computation can be employed not only for self-administration but also for other behavioral paradigms to advance pharmacokinetic/pharmacodynamic modeling. PMID:15878149

  13. Drug-resin drug interactions in patients with delayed gastric emptying: What is optimal time window for drug administration?

    PubMed

    Camilleri, M

    2016-08-01

    Most drug-drug interactions involve overlap or competition in drug metabolic pathways. However, there are medications, typically resins, whose function is to bind injurious substances such as bile acids or potassium within the digestive tract. The objective of this article is to review the functions of the stomach and the kinetics of emptying of different food forms or formulations to make recommendations on timing of medication administration in order to avoid intragastric drug interactions. Based on the profiles and kinetics of emptying of liquid nutrients and homogenized solids, a window of 3 h between administration of a resin drug and another 'target' medication would be expected to allow a median of 80% of medications with particle size <1 mm to empty from the stomach and, hence, avoid potential interaction such as binding of the 'target' medication within the stomach. PMID:26987693

  14. Multiple routes of drug administration and HIV risk among injecting drug users

    PubMed Central

    Vorobjov, Sigrid; Uusküla, Anneli; Des Jarlais, Don C.; Abel-Ollo, Katri; Talu, Ave; Rüütel, Kristi

    2011-01-01

    This study assesses relationships between drug administration routes and HIV serostatus, drug-use and sexual behaviors among current injecting drug users (IDUs) in Tallinn, Estonia. We recruited 350 IDUs for a cross-sectional risk behavior survey. Adjusted odds ratios (AORs) were calculated to explore injection risk behavior, sexual behavior and HIV serostatus associated with multiple route use. Focus groups explored reasons why injectors might use non-injecting routes of administration. Those reporting multiple drug administration routes were less likely to be HIV seropositive (AOR 0.49; 95%CI 0.25-0.97), had almost twice the odds of having more than one sexual partner (AOR 1.90; 95%CI 1.01-3.60) and of reporting having sexually transmitted diseases (AOR 2.38; 95%CI 1.02-5.59). IDUs who engage in non-injecting drug use may be reducing their risk of acquiring HIV though sharing injection equipment, but if infected may be a critical group for sexual transmission of HIV to people who do not inject drugs. PMID:22116012

  15. Is tobacco a drug? Administrative agencies as common law courts.

    PubMed

    Sunstein, C R

    1998-04-01

    Professor Cass Sunstein argues that the FDA has the authority to regulate tobacco products. He considers the text of the Federal Food, Drug, and Cosmetic Act, which supports the FDA assertion, and the context of its enactment, which argues against the FDA. He resolves the tension between text and context in favor of FDA jurisdiction by turning to the emerging role of administrative agencies. In modern government, he contends, administrative agencies have become America's common law courts, with the power to adapt statutory regimes to new facts and new values when the underlying statute is ambiguous. Professor Sunstein's Article, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit. PMID:10557544

  16. How the US Food and Drug Administration Can Solve the Prescription Drug Shortage Problem

    PubMed Central

    2013-01-01

    Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections’ focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed—the most frequent cause of drug shortages. PMID:23488502

  17. How are drugs approved? Part 1: the evolution of the Food and Drug Administration.

    PubMed

    Howland, Robert H

    2008-01-01

    The discovery, development, and marketing of drugs for clinical use is a process that is complex, arduous, expensive, highly regulated, often criticized, and sometimes controversial. In the United States, the Food and Drug Administration (FDA) is the governmental agency responsible for regulating the development and marketing of drugs, medical devices, biologics, foods, cosmetics, radiation-emitting electronic devices, and veterinary products, with the objective of ensuring their safety and efficacy. As part of a broad overview of the drug development process, this article will describe the historical evolution of the FDA. This will provide background for two subsequent articles in this series, which will describe the ethical foundations of clinical research and hethe stages of drug development. PMID:18251347

  18. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... Global Regulatory Environment AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public... Life Cycle in a Global Regulatory Environment.'' The conference will cover current issues affecting the... facilitate the development and continuous improvement of safe and effective medical products. The...

  19. Catheter Obstruction of Intrathecal Drug Administration System -A Case Report-

    PubMed Central

    Rhee, Seok Myeon; Choi, Eun Joo; Lee, Pyung Bok

    2012-01-01

    Intrathecal drug administration system (ITDAS) can reduce the side effects while increasing the effectiveness of opioids compared to systemic opioid administration. Therefore, the use of ITDAS has increased in the management of cancer pain and chronic intractable pain. Catheter obstruction is a serious complication of ITDAS. Here, we present a case of catheter obstruction by a mass formed at the side hole and in the lumen. A 37-year-old man suffering from failed back surgery syndrome received an ITDAS implantation, and the ITDAS was refilled with morphine every 3 months. When the patient visited the hospital 18 months after ITDAS implantation for a refill, the amount of delivered morphine sulfate was much less than expected. Movement of the pump rotor was examined with fluoroscopy; however, it was normal. CSF aspiration through the catheter access port was impossible. When the intrathecal catheter was removed, we observed that the side hole and lumen of the catheter was plugged. PMID:22259717

  20. Food and Drug Administration regulation and evaluation of vaccines.

    PubMed

    Marshall, Valerie; Baylor, Norman W

    2011-05-01

    The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency. PMID:21502242

  1. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  2. 78 FR 42381 - Administrative Detention of Drugs Intended for Human or Animal Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... regulations for the administrative detention of drugs (78 FR 21085). The docket was intended to ensure that... July 15, 2013 Part IV Department of Health and Human Services Food and Drug Administration 21 CFR Parts... / Proposed Rules#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts...

  3. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... reportable food that is the subject of a summary posting and that are part of a chain of establishments with... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  4. 77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  5. 76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of...

  6. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of...

  7. 78 FR 6332 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of...

  8. 77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of...

  9. 49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false FRA Administrator's determination of random drug... (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random...

  10. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice.... In the Federal Register of July 21, 2011 (76 FR 43689), FDA announced the availability of the...

  11. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.111 Data and information...

  12. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  13. 21 CFR 20.32 - Disclosure of Food and Drug Administration employee names.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Disclosure of Food and Drug Administration employee names. 20.32 Section 20.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.32 Disclosure of Food and...

  14. 21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Conflict of Interest Review Board. 19.10 Section 19.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST General Provisions § 19.10...

  15. 21 CFR 20.31 - Retention schedule of requests for Food and Drug Administration records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Retention schedule of requests for Food and Drug Administration records. 20.31 Section 20.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.31 Retention schedule of requests for...

  16. 21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Data and information submitted voluntarily to the Food and Drug Administration. 20.111 Section 20.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.111 Data and information...

  17. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and...

  18. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  19. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  20. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  1. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Policy on disclosure of Food and Drug Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.20 Policy on disclosure of Food and...

  2. 78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug... Administration Safety and Innovation Act (FDASIA). This document is intended to solicit input from all relevant..., and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to provide FDA administrative detention...

  3. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Federal Bureau of Investigation, Drug... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of.... (a) The Director of the Federal Bureau of Investigation, the Administrator......

  4. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Federal Bureau of Investigation, Drug... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of.... (a) The Director of the Federal Bureau of Investigation, the Administrator......

  5. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Federal Bureau of Investigation, Drug... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of.... (a) The Director of the Federal Bureau of Investigation, the Administrator......

  6. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Federal Bureau of Investigation, Drug... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of.... (a) The Director of the Federal Bureau of Investigation, the Administrator......

  7. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Federal Bureau of Investigation, Drug... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of.... (a) The Director of the Federal Bureau of Investigation, the Administrator......

  8. Pediatric Mechanical Circulatory Support

    PubMed Central

    Lorts, Angela; Morales, David

    2013-01-01

    Mechanical circulatory support (MCS) in the pediatric heart failure population has a limited history especially for infants, and neonates. It has been increasingly recognized that there is a rapidly expanding population of children diagnosed and living with heart failure. This expanding population has resulted in increasing numbers of children with medically resistant end-stage heart failure. The traditional therapy for these children has been heart transplantation. However, children with heart failure unlike adults do not have symptoms until they present with end-stage heart failure and therefore, cannot safely wait for transplantation. Many of these children were bridged to heart transplantation utilizing extracorporeal membranous oxygenation as a bridge to transplant which has yielded poor results. As such, industry, clinicians, and the government have refocused interest in developing increasing numbers of MCS options for children living with heart failure as a bridge to transplantation and as a chronic therapy. In this review, we discuss MCS options for short and long-term support that are currently available for infants and children with end-stage heart failure. PMID:24368965

  9. Modeling of Corneal and Retinal Pharmacokinetics after Periocular Drug Administration

    PubMed Central

    Amrite, Aniruddha C.; Edelhauser, Henry F.; Kompella, Uday B.

    2012-01-01

    .99) with the observed values in the SD rat corneas. Similar pharmacokinetics models explain drug delivery to the cornea in rat and rabbit animal models. Retinal pharmacokinetics after periocular drug administration can be explained with a four-compartment (periocular space, choroid-containing transfer compartment, retina, and distribution compartment) model with elimination from the periocular space, retina, and choroid compartment. Inclusion of a dissolution–release step before the drug is available for absorption or elimination better explains retinal tmax. Good fits were obtained in both the BN (r = 0.99) and SD (r = 0.99) rats for retinal celecoxib using the same model; however, the parameter estimates differed. Conclusions Corneal and retinal pharmacokinetics of small lipophilic molecules after periocular administration can be described by compartment models. The modeling analysis shows that (1) leak-back from the site of administration most likely contributes to the apparent lack of an increase phase in corneal concentrations; (2) elimination via the conjunctival or periocular blood and lymphatic systems contributes significantly to drug clearance after periocular injection; (3) corneal pharmacokinetics of small lipophilic molecules can be explained by using similar models in rats and rabbits; and (4) although there are differences in some retinal pharmacokinetics parameters between the pigmented and nonpigmented rats, the physiological basis of these differences has yet to be ascertained. PMID:18172109

  10. DEWORMING DELUSIONS? MASS DRUG ADMINISTRATION IN EAST AFRICAN SCHOOLS.

    PubMed

    Allen, Tim; Parker, Melissa

    2016-09-01

    Recent debates about deworming school-aged children in East Africa have been described as the 'Worm Wars'. The stakes are high. Deworming has become one of the top priorities in the fight against infectious diseases. Staff at the World Health Organization, the Gates Foundation and the World Bank (among other institutions) have endorsed the approach, and school-based treatments are a key component of large-scale mass drug administration programmes. Drawing on field research in Uganda and Tanzania, and engaging with both biological and social evidence, this article shows that assertions about the effects of school-based deworming are over-optimistic. The results of a much-cited study on deworming Kenyan school children, which has been used to promote the intervention, are flawed, and a systematic review of randomized controlled trials demonstrates that deworming is unlikely to improve overall public health. Also, confusions arise by applying the term deworming to a variety of very different helminth infections and to different treatment regimes, while local-level research in schools reveals that drug coverage usually falls below target levels. In most places where data exist, infection levels remain disappointingly high. Without indefinite free deworming, any declines in endemicity are likely to be reversed. Moreover, there are social problems arising from mass drug administration that have generally been ignored. Notably, there are serious ethical and practical issues arising from the widespread practice of giving tablets to children without actively consulting parents. There is no doubt that curative therapy for children infected with debilitating parasitic infections is appropriate, but overly positive evaluations of indiscriminate deworming are counter-productive. PMID:27428063

  11. Suspected drug eruption in seven dogs during administration of flucytosine.

    PubMed

    Malik, R; Medeiros, C; Wigney, D I; Love, D N

    1996-10-01

    7 of 8 dogs receiving combination drug therapy consisting of flucytosine together with amphotericin B and/or a triazole for cryptococcosis or aspergillosis developed cutaneous or mucocutaneous eruptions during the course of treatment. Lesions resolved in all cases following discontinuation of flucytosine despite continued administration of other antifungals, suggesting the eruption was referable primarily to the flucytosine component of therapy. Lesions developed 13 to 41 days (median 20 days) after commencing flucytosine (105 to 188 mg/kg/day divided and given every 8 h; median dose rate 150 mg/kg/day). The cumulative dose of flucytosine given prior to the first signs of the drug eruption ranged from 1.7 to 6.8 g/kg (median 2.3 g/kg). The eruptions consisted of depigmentation, followed by ulceration, exudation and crust formation. The scrotum was affected in all 4 male dogs, the nasal plane in 6 of 7 cases, while the lips, vulva, external ear canal and integument were involved in a smaller number of cases. There was considerable variation in the severity of lesions, with changes being most marked when flucytosine was continued for several days after lesions first appeared. Some dogs experienced malaise and inappetence in association with the suspected drug eruption. Healing took a variable period, typically in excess of 2 weeks after discontinuing flucytosine, with up to 2 months being required for total resolution of the lesions. All lesions resolved eventually without scarring or permanent loss of pigment. PMID:8937669

  12. Preparation of intravenous drug administration guidelines for a pediatric intensive care unit.

    PubMed

    Manrique-Rodríguez, Silvia; Sánchez-Galindo, Amelia; Fernández-Llamazares, Cecilia M; López-Herce, Jesús; Rodríguez-Gómez, Milagrosa; Echarri-Martínez, Lara; Carrillo-Álvarez, Angel; Sanjurjo-Sáez, María

    2014-01-01

    Drug administration is one of the main sources of errors in pediatric intensive care units (PICUs). An available guide for intravenous drug administration might be useful. The aim of this article is to present the methodology and results for the development of a guide for intravenous drug administration in a PICU. A total of 116 drugs were included. Standard concentrations, diluents, technique for reconstitution and dilution, stability, rate of administration, and relevant observations were defined for each drug according to a review of the most commonly used literature resources. The main unique feature of this article is that it includes standard concentrations for each drug. PMID:24384883

  13. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... CONTACT: Samie Allen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New... HUMAN SERVICES Food and Drug Administration Guidance for Industry and......

  14. US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.

    PubMed

    Lathrop, Julia Tait; Jeffery, Douglas A; Shea, Yvonne R; Scholl, Peter F; Chan, Maria M

    2016-01-01

    Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic. PMID:26553791

  15. Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

    PubMed Central

    Kaufman, Annette R.; Waters, Erika A.; Parascandola, Mark; Augustson, Erik M.; Bansal-Travers, Maansi; Hyland, Andrew; Cummings, K. Michael

    2013-01-01

    Objectives To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. Methods A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. Results Smokers reporting that the FDA does not evaluate cigarettes for safety (46.1%), exhibited greater comprehension of the health risks of smoking and were more likely (48.5%) than other participants (33.6%) to report quit intentions. Risk perceptions partially mediated the relationship between FDA evaluation belief and quit intentions. Conclusions These findings highlight the need for proactive, effective communication to the public about the aims of new tobacco product regulations. PMID:22251767

  16. Food and Drug Administration workshop on indirect mechanisms of carcinogenesis.

    PubMed

    Poirier, L A

    1996-01-01

    A workshop sponsored by the Food and Drug Administration (FDA) was held on March 4-5, 1996, at the Lister Hill Auditorium of the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop considered both the scientific aspects and the regulatory implications of indirect-acting carcinogens. A wide variety of agents and of prospective mechanisms was discussed. The organizing committee for the workshop consisted of Drs. James Farrelly and Joseph DeGeorge of the Center for Drug Evaluation and Research (CDER), Ronald J. Lorentzen and Sidney Green of the Center for Food Safety and Applied Nutrition (CFSAN), Martin D. Green of the Center for Biologics, Evaluation and Research (CBER), C. Darnell Jackson and Lionel A. Poirier of the National Center for Toxicological Research (NCTR). Rosalie K. Elespuru of the Center for Devices and Radiological Health (CDRH), and David G. Longfellow of the National Cancer Institute (NCI). Following an introduction by Dr. Poirier, who provided a description of indirect carcinogens, the major talks were grouped into three formal sessions: indirect-acting compounds and agents of FDA interest, biological and biochemical endpoints commonly seen with indirect agents, and specific problems associated with the indirect-acting compounds. A panel discussion followed and the concluding remarks were made by Dr. Bernard A. Schwetz, Associate Commissioner for Science, FDA. PMID:8923694

  17. 21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration Conflict of Interest... and Drug Administration Conflict of Interest Review Board. (a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall review and make recommendations to...

  18. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  19. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  20. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  1. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  2. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear, nose, and throat drug administration device... SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. An ear, nose, and throat...

  3. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  4. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  5. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  6. 21 CFR 7.45 - Food and Drug Administration-requested recall.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration-requested recall. 7... GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner...

  7. 75 FR 4982 - Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    .... ACTION: Final rule. SUMMARY: Under delegated authority, the Administrator of the Drug Enforcement... Substances Act and subsequently delegated to the Administrator of DEA. DATES: Effective Dates: This Final... Attorney General has delegated his functions under the CSA to the Administrator of the Drug...

  8. 77 FR 55845 - Science Board to the Food and Drug Administration: Request for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration: Request... Administration (FDA) is requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to... given first consideration for membership on the Science Board. Nominations received after October...

  9. National Mass Drug Administration Costs for Lymphatic Filariasis Elimination

    PubMed Central

    Goldman, Ann S.; Guisinger, Victoria H.; Aikins, Moses; Amarillo, Maria Lourdes E.; Belizario, Vicente Y.; Garshong, Bertha; Gyapong, John; Kabali, Conrad; Kamal, Hussein A.; Kanjilal, Sanjat; Kyelem, Dominique; Lizardo, Jefrey; Malecela, Mwele; Mubyazi, Godfrey; Nitièma, P. Abdoulaye; Ramzy, Reda M. R.; Streit, Thomas G.; Wallace, Aaron; Brady, Molly A.; Rheingans, Richard; Ottesen, Eric A.; Haddix, Anne C.

    2007-01-01

    Background Because lymphatic filariasis (LF) elimination efforts are hampered by a dearth of economic information about the cost of mass drug administration (MDA) programs (using either albendazole with diethylcarbamazine [DEC] or albendazole with ivermectin), a multicenter study was undertaken to determine the costs of MDA programs to interrupt transmission of infection with LF. Such results are particularly important because LF programs have the necessary diagnostic and treatment tools to eliminate the disease as a public health problem globally, and already by 2006, the Global Programme to Eliminate LF had initiated treatment programs covering over 400 million of the 1.3 billion people at risk. Methodology/Principal Findings To obtain annual costs to carry out the MDA strategy, researchers from seven countries developed and followed a common cost analysis protocol designed to estimate 1) the total annual cost of the LF program, 2) the average cost per person treated, and 3) the relative contributions of the endemic countries and the external partners. Costs per person treated ranged from $0.06 to $2.23. Principal reasons for the variation were 1) the age (newness) of the MDA program, 2) the use of volunteers, and 3) the size of the population treated. Substantial contributions by governments were documented – generally 60%–90% of program operation costs, excluding costs of donated medications. Conclusions/Significance MDA for LF elimination is comparatively inexpensive in relation to most other public health programs. Governments and communities make the predominant financial contributions to actual MDA implementation, not counting the cost of the drugs themselves. The results highlight the impact of the use of volunteers on program costs and provide specific cost data for 7 different countries that can be used as a basis both for modifying current programs and for developing new ones. PMID:17989784

  10. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is...

  11. Zohydro approval by food and drug administration: controversial or frightening?

    PubMed

    Manchikanti, Laxmaiah; Atluri, Sairam; Candido, Kenneth D; Boswell, Mark V; Simopoulos, Thomas T; Grider, Jay S; Falco, Frank J E; Hirsch, Joshua A

    2014-01-01

    The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health

  12. Cell-Mediated Delivery of Nanoparticles: Taking Advantage of Circulatory Cells to Target Nanoparticles

    PubMed Central

    Anselmo, Aaron C.; Mitragotri, Samir

    2014-01-01

    Cellular hitchhiking leverages the use of circulatory cells to enhance the biological outcome of nanoparticle drug delivery systems, which often suffer from poor circulation time and limited targeting. Cellular hitchhiking utilizes the natural abilities of circulatory cells to: (i) navigate the vasculature while avoiding immune system clearance, (ii) remain relatively inert until needed and (iii) perform specific functions, including nutrient delivery to tissues, clearance of pathogens, and immune system surveillance. A variety of synthetic nanoparticles attempt to mimic these functional attributes of circulatory cells for drug delivery purposes. By combining the advantages of circulatory cells and synthetic nanoparticles, many advanced drug delivery systems have been developed that adopt the concept of cellular hitchhiking. Here, we review the development and specific applications of cellular hitchhiking-based drug delivery systems. PMID:24747161

  13. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Notwithstanding the provisions of 28 CFR 0.104, the Administrator of DEA is authorized to redelegate the power and... ORGANIZATION OF THE DEPARTMENT OF JUSTICE Drug Enforcement Administration § 0.103a Delegations respecting... Associate Chief Counsel level....

  14. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  15. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  16. 78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... HUMAN SERVICES Food and Drug Administration The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration's (FDA) Office of Orphan Products...

  17. 77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...

  18. The food and drug administration agrees to classify mercury fillings.

    PubMed

    Edlich, Richard F; Cross, Catherine L; Wack, Courtney A; Long, William B; Newkirk, Anthony T

    2008-01-01

    In the United States Court of Appeals of the District of Columbia Circuit, the Appellants Mom's Against Mercury, Connecticut Coalition for Environmental Justice, Oregonians for Life, California Citizens for Health Freedom, Kevin J. Biggers, Karen Johnson, Linda Brocato, R. Andrew Landerman, and Antia Vazquez Tibaul filed a petition for review of Regulatory Inaction by the Food and Drug Administration (FDA). On Monday June 2, 2008, the lawsuit was settled with the FDA after it agreed to classify mercury fillings. During its negotiation session with the Appellants, the FDA indicated that it would change its website on mercury fillings. The FDA no longer claims that no science exists about the safety of mercury amalgam or that other countries have acted for environmental reasons only. On its website, the FDA now states the following: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus." The FDA also states that "Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner." The FDA decision to classify mercury fillings is a reflection of the legislations enacted in Europe and Canada that highlight the neurotoxic effects of mercury fillings. PMID:19105536

  19. 38 CFR 4.62 - Circulatory disturbances.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... FOR RATING DISABILITIES Disability Ratings The Musculoskeletal System § 4.62 Circulatory disturbances. The circulatory disturbances, especially of the lower extremity following injury in the popliteal... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Circulatory...

  20. 38 CFR 4.62 - Circulatory disturbances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... FOR RATING DISABILITIES Disability Ratings The Musculoskeletal System § 4.62 Circulatory disturbances. The circulatory disturbances, especially of the lower extremity following injury in the popliteal... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Circulatory...

  1. 38 CFR 4.62 - Circulatory disturbances.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... FOR RATING DISABILITIES Disability Ratings The Musculoskeletal System § 4.62 Circulatory disturbances. The circulatory disturbances, especially of the lower extremity following injury in the popliteal... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Circulatory...

  2. 38 CFR 4.62 - Circulatory disturbances.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... FOR RATING DISABILITIES Disability Ratings The Musculoskeletal System § 4.62 Circulatory disturbances. The circulatory disturbances, especially of the lower extremity following injury in the popliteal... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Circulatory...

  3. 38 CFR 4.62 - Circulatory disturbances.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... FOR RATING DISABILITIES Disability Ratings The Musculoskeletal System § 4.62 Circulatory disturbances. The circulatory disturbances, especially of the lower extremity following injury in the popliteal... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Circulatory...

  4. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  5. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  6. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  7. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act...

  8. 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures...

  9. [Transfusion-associated circulatory overload].

    PubMed

    Ozier, Y; Mouquet, F; Rieux, C; Mertes, P-M; Muller, J-Y; Caldani, C; Boudjedir, K; Carlier, M

    2012-11-01

    A working group of the French National Hemovigilance Committee has been in charge of heightening awareness of Transfusion-Associated Circulatory Overload (TACO) among physicians and nurses. This multidisciplinary group has produced the present document that focuses on epidemiological data provided by the French haemovigilance network, physiopathology, diagnosis, treatment and specific actions that could prevent or minimize the risk of TACO. PMID:23039960

  10. Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.

    PubMed

    Jensen, Valerie; Throckmorton, Douglas C

    2015-08-01

    Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential. PMID:25896999

  11. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design... study design principles relevant to the development of medical device clinical studies that can be...

  12. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1646, Silver Spring... the Internet. A search capability for all Center for Devices and Radiological Health (CDRH) guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and......

  13. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical...

  14. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati,...

  15. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... conference will be held on the campus of Xavier University, 3800 Victory Pkwy., ] Cincinnati, OH 45207, 513... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical...

  16. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical...

  17. 75 FR 11893 - Food and Drug Administration Transparency Task Force; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-12

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Task Force... transparent, collaborative, and participatory government. FDA has formed an internal Transparency Task Force..., the Task Force has held two public meetings, on June 24, 2009, and November 3, 2009, and established...

  18. 77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ..., (76 FR 3825, January 21, 2011), FDA recounted the actions it had already implemented, as well as those... of availability of this report on October 4, 2011 (76 FR 61366), FDA sought public comment on these... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency...

  19. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  20. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the... FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual...

  1. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  2. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... announcing a public workshop entitled ``FDA Clinical Trial Requirements, Regulations, Compliance, and Good... representatives. The program will focus on the relationships among the FDA and clinical trial staff,...

  3. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  4. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  5. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  6. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements... public workshop on FDA's clinical trial requirements is designed to aid the clinical research... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical...

  7. [Circulatory survival of irreversible comas].

    PubMed

    Cartier, F; Chevet, D; Garré, M; Launois, B; Thomas, R; Le Pollès, R

    1975-01-18

    On the basis of a series of 53 cases of irreversible coma maintained in circulatory survival with the aim of removing the kidneys, the authors discuss the mode of treatment, with particular reference to the intravenous fluids used and the use of medications influencing the circulation. Fluid and electrolytes given must be adjusted hourly to ensure the exact replacement of urinary losses. Isoprotenerol is the only medication usually necessary. In the event of circulatory insufficiency, which is difficult to foresee and hence prevent, immediate volume expansion in a short a time as possible and isoprotenerol most frequently correct the situation (14 out of 17 cases). Thus effective circulation may be maintained until the kidneys are removed (48 out of 53 cases). 92 p.cent of the grafted kidneys functioned from the first day onwards. PMID:1093120

  8. Update on administration of anesthetics and psychoactive drugs for pain management in China.

    PubMed

    Gu, Weiping

    2015-06-01

    Anesthetics and psychoactive drugs could relieve diseases, if used properly. However, they can cause dependency, and their misuse or abuse could adversely affect people's health and social stability. For a long time, the Chinese government has been reinforcing the regulation on anesthetics and psychoactive drugs to ensure their legal and proper usage, and to prevent abuse. The state council issued 'the regulations on the administration of anesthetic drugs and psychotropic drugs' in 2005, based on which a legal system was established for administration of anesthetics and psychoactive drugs with the objectives of ensuring their legitimate medical utilization, and preventing illegal abuse. PMID:26068438

  9. Administrator's Handbook for Crime Prevention and Drug Education.

    ERIC Educational Resources Information Center

    Texas Education Agency, Austin. Div. of Crime Prevention and Drug Education.

    Acts of three Texas Legislatures have mandated that the schools of Texas provide a program for all public school students, grades K-12, in crime prevention and drug education. To assist schools in formulating a philosophy about and in developing appropriate programs and techniques for drug education and crime prevention programs, the Texas…

  10. [Drugs administration by subcutaneous injection within palliative care].

    PubMed

    Tanguy-Goarin, Charlotte; Cogulet, Virginie

    2010-01-01

    Drugs delivery by subcutaneous injection is often the last resort/appeal for a doctor anxious to limit the aggressive and invasive treatments, particularly within palliative care. A review was made to list the drugs which can be administered by this route. Concerned antibiotics are teicoplanin, netilmicin and gentamicin with a risk of skin necrosis for aminoglycosids. Midazolam is useful in various indications and can be associated with morphine in case of dyspnoea. Data about subcutaneous injection of dexamethasone, clonazepam, haloperidol and levomepromazine are published; it is the same for fentanyl, nefopam, ondansetron and metoclopramide. The subcutaneous injection of these quoted drugs is possible, but requires further studies. PMID:21176759

  11. The administration of sulfonamide drugs to adult salmon

    USGS Publications Warehouse

    Amend, D.F.; Fryer, J.L.

    1968-01-01

    Mass treatment is the most convenient way to combat fish diseases. For example, drugs can be administered per os in diets, or chemicals can be added to the water. These methods are mostly ineffective in treating systemic infections of adult salmon because mature salmon do not feed, and many fish diseases cannot be controlled by chemical baths. Thus, effective treatment would require administering drugs to each individual.

  12. Administrative Destruction of Certain Drugs Refused Admission to the United States. Final rule.

    PubMed

    2015-09-15

    The Food and Drug Administration (FDA or Agency) is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by issuing a rule that provides to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to destruction. This regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Implementation of this authority will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain. PMID:26387150

  13. Intrapulmonary drug administration in neonatal and paediatric critical care: a comprehensive review.

    PubMed

    De Luca, D; Cogo, P; Zecca, E; Piastra, M; Pietrini, D; Tridente, A; Conti, G; Carnielli, V P

    2011-03-01

    Administration of drugs directly into the respiratory tree first was proposed a long time ago. Surfactant is the paradigmatic example of such therapies. Many other drugs have been used in the same way and further compounds are under investigation for this aim. In the last two decades, despite the wide number of drugs available for direct lung administration in critical care patients, few controlled data exist regarding their use in neonates and infants. This review will focus on drugs clinically available in a critical care setting for neonates and infants, including bronchodilators, pulmonary vasodilators, anti-inflammatory agents, mucolytics, resuscitative anti-infective agents, surfactants and other drugs. We provide an evidence-based comprehensive review of drugs available for intratracheal administration in paediatric and neonatal critical care and we examine possible advantages and risks for each proposed indication. PMID:21357925

  14. Cardiovascular devices; reclassification of nonroller-type cardiopulmonary bypass blood pumps for cardiopulmonary and circulatory bypass; effective date of requirement for premarket approval for nonroller-type cardiopulmonary bypass blood pumps for temporary ventricular support. Final order.

    PubMed

    2015-06-01

    The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order. PMID:26054096

  15. Evaluation of teratogenic effects of risperidone following simultaneous administration with antihypertensive and antiemetic drugs.

    PubMed

    Tauqeer, Shaista; Khan, Rafeeq Alam; Siddiqui, Afaq Ahmed

    2012-01-01

    Multiple drug administration is an important aspect of clinical practice particularly in specific physiological situation such as in neonates, elderly or pregnancy, since in all such situations, possibility of unwanted effects increases due to altered body physiology. In present study, the teratogenic effects of multiple drug administration risperidone, meclizine/pyridoxine and hydralazine have been compared with the teratogenic effects of individual drugs in pregnant mice. Moreover the role of folic acid and α-tocopherol if any had also been investigated in reducing the teratogenic effects of these drugs in combinations. PMID:22186339

  16. Technology assessment and the Food and Drug Administration

    NASA Technical Reports Server (NTRS)

    Kaplan, A. H.; Becker, R. H.

    1972-01-01

    The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

  17. Drug-Induced Pancreatitis: A Rare Manifestation of Doxycycline Administration

    PubMed Central

    Inayat, Faisal; Virk, Hafeez Ul Hassan; Yoon, Daniel J.; Riaz, Iqra

    2016-01-01

    Context: Drug-induced pancreatitis (DIP) is rare, but as there are no systematic data on it, the true incidence is not known. Although numerous and varied drugs have been associated with DIP, the clinical evidence on doxycycline-induced pancreatitis is sparse. Case Report: We present the case of a 58-year-old female who presented with complaints of nausea and severe epigastric pain. Her medications included doxycycline which she had been on for only 2 days. Computed tomography of her abdomen showed mild enlargement of body of the pancreas with peripancreatic fatty infiltration, along with lipase level suggestive of acute pancreatitis. In the absence of classical risk factors for acute pancreatitis, a diagnosis of DIP secondary to doxycycline therapy was made. Immediate withdrawal of the drug was accompanied by relief of symptoms and resolution of pancreatitis. Conclusion: This report implicates doxycycline as an etiological factor for acute pancreatitis. Knowledge regarding doxycycline related pancreatitis is of paramount importance in order to diagnose cases early and institute effective treatment in patients who are undergoing therapy with this drug. PMID:27042611

  18. 76 FR 14030 - Extension of Memorandum of Understanding Between the Food and Drug Administration and Servicio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... and Drug Administration and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the... Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States. The purpose of the MOU is...

  19. 76 FR 31345 - Cooperative Arrangement Between the United States Food and Drug Administration and the Inter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... Drug Administration and the Inter-American Institute for Cooperation in Agriculture AGENCY: Food and... Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to...

  20. 75 FR 60767 - Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... HUMAN SERVICES Food and Drug Administration Office of the Commissioner; Request for Comments on the Food... AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and...- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR...

  1. [Circulatory assist devices in cardiology].

    PubMed

    Ferrari, M; Figulla, H R

    2005-03-24

    One out of 13 patients with an acute myocardial infarction is endangered of cardiogenic shock. In addition, acute valvular leakage, shunt vitiae, and acute myocarditis can lead to acute myocardial failure. As a therapeutic option, mechanical assist devices offer cardiac support and hemodynamic stabilization under these circumstances. The following minimal-invasive devices are used in cardiology and intensive care medicine: intra-aortic balloon pulsation (IABP), intra-vascular axial screw pumps, extra-corporal centrifugal pumps with and without additional membrane oxygenator. The IABP improves left ventricular function by a systolic reduction of the after-load, and an increase of diastolic blood pressure dependent on myocardial function. In contrast, axial screw pumps and centrifugal pumps can provide circulatory support independently of myocardial function. Mechanical assist devices can prevent irreversible damage not only by offering a reduction of myocardial work load, but also by improving organ perfusion in cardiogenic shock situations. Another indication for mechanical circulatory support depicts high-risk coronary angioplasty if the left ventricular ejection fraction is severely reduced or the target vessel supplies more than 50 % of vital myocardium. In case of irreversible heart failure, turbine pumps or centrifugal pumps offer a stabilization for the patient's transfer to a cardiac surgery center. They can also be used for bridging to heart transplantation in acute situations. Technical improvements will enhance the use of mechanical assist devices in the near future. Especially the development of portable emergency devices will enrich therapeutic possibilities in cardiology and intensive care medicine. PMID:15776348

  2. Rectal drug administration in adults: how, when, why.

    PubMed

    Lowry, Michael

    Administering medication per rectum can be the most appropriate route for some patients may not always be considered by health professionals. Cultural sensitivities, as well as misinformation regarding insertion methods, may be barriers to the practice. This article explains how the rectal route functions in drug absorption, clarifies when this route is appropriate to use and outlines the steps nurses should follow to prepare patients adequately and safely to carry out the procedure. PMID:27071237

  3. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Food and Drug Administration Web site at http://www.fda.gov once finalized. (c) Agreements and... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD...

  4. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD AND... Specific Categories of Records § 20.108 Agreements between the Food and Drug Administration and...

  5. 21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records §...

  6. 21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. 170.105 Section 170.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION...

  7. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.105 Section 20.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.105 Testing...

  8. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.105 Section 20.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.105 Testing...

  9. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.105 Section 20.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.105 Testing...

  10. 77 FR 38173 - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Drug Administration (FDA) published in the Federal Register of March 23, 2012 (77 FR 16923), a direct... Agency received significant adverse comment. DATES: The direct final rule published at 77 FR 16923, March... and Drugs, the direct final rule published in the Federal Register on March 23, 2012 (77 FR 16923)...

  11. Drug Administration Errors in an Institution for Individuals with Intellectual Disability: An Observational Study

    ERIC Educational Resources Information Center

    van den Bemt, P. M. L. A.; Robertz, R.; de Jong, A. L.; van Roon, E. N.; Leufkens, H. G. M.

    2007-01-01

    Background: Medication errors can result in harm, unless barriers to prevent them are present. Drug administration errors are less likely to be prevented, because they occur in the last stage of the drug distribution process. This is especially the case in non-alert patients, as patients often form the final barrier to prevention of errors.…

  12. 21 CFR 20.30 - Food and Drug Administration Division of Freedom of Information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration Division of Freedom... Division of Freedom of Information. (a) The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Information (ELEM-1029), Food and...

  13. 21 CFR 20.30 - Food and Drug Administration Division of Freedom of Information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration Division of Freedom... Division of Freedom of Information. (a) The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Information (ELEM-1029), Food and...

  14. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20... opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and...

  15. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20... opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and...

  16. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20... opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and...

  17. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... surveillance processes, including application submission, review, compliance with good manufacturing practices... good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation...://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm . Recognizing that many...

  18. 75 FR 17418 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Administration, United States Department of Health and Human Services and the National Alliance for Hispanic Health AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  19. U.S. Food and Drug Administration. "Evaluation Criteria" for Difficult to Compound Drugs.

    PubMed

    Allen, Loyd V

    2015-01-01

    This is part 2 of a 2-part article on the topic of Nominations of Difficult to Compound Drugs to the FDA-PCAC. Part 1 provided a current list of Nominations of Difficult to Compound Drugs to the FDA-PCAC. This article discusses the evaluation procedure for determining which drugs are demonstrably difficult to compound. PMID:26891563

  20. Drug administration in animal studies of cardiac arrest does not reflect human clinical experience

    PubMed Central

    Reynolds, Joshua C.; Rittenberger, Jon C.; Menegazzi, James J.

    2007-01-01

    Introduction To date, there is no evidence showing a benefit from any advanced cardiac life support (ACLS) medication in out-of-hospital cardiac arrest (OOHCA), despite animal data to the contrary. One explanation may be a difference in the time to first drug administration. Our previous work has shown the mean time to first drug administration in clinical trials is 19.4 minutes. We hypothesized that the average time to drug administration in large animal experiments occurs earlier than in OOHCA clinical trials. Methods We conducted a literature review between 1990 and 2006 in MEDLINE using the following MeSH headings: swine, dogs, resuscitation, heart arrest, EMS, EMT, ambulance, ventricular fibrillation, drug therapy, epinephrine, vasopressin, amiodarone, lidocaine, magnesium, and sodium bicarbonate. We reviewed the abstracts of 331 studies and 197 full manuscripts. Exclusion criteria included: non-peer reviewed, all without primary animal data, and traumatic models. From these, we identified 119 papers that contained unique information on time to medication administration. The data are reported as mean, ranges, and 95% confidence intervals. Mean time to first drug administration in animal laboratory studies and clinical trials was compared with a t-test. Regression analysis was performed to determine if time to drug predicted ROSC. Results Mean time to first drug administration in 2378 animals was 9.5 minutes (range 3.0–28.0; 95% CI around mean 2.78, 16.22). This is less than the time reported in clinical trials (19.4 min, p<0.001). Time to drug predicted ROSC (Odds Ratio 0.844; 95% CI 0.738, 0.966). Conclusion Shorter drug delivery time in animal models of cardiac arrest may be one reason for the failure of animal studies to translate successfully into the clinical arena. PMID:17360097

  1. Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010622

  2. Factors Influencing Drug Uptake during Mass Drug Administration for Control of Lymphatic Filariasis in Rural and Urban Tanzania

    PubMed Central

    Kisoka, William J.; Simonsen, Paul E.; Malecela, Mwelecele N.; Tersbøl, Britt P.; Mushi, Declare L.; Meyrowitsch, Dan W.

    2014-01-01

    Background In most countries of Sub-Saharan Africa, control of lymphatic filariasis (LF) is based on annual mass drug administration (MDA) with a combination of ivermectin and albendazole. Treatment coverages are however often suboptimal for programmes to reach the goal of transmission interruption within reasonable time. The present study aimed to identify predictors and barriers to individual drug uptake during MDA implementation by the National LF Elimination Programme in Tanzania. Methods A questionnaire based cross sectional household survey was carried out in two rural and two urban districts in Lindi and Morogoro regions shortly after the 2011 MDA. 3279 adults (≥15 years) were interviewed about personal characteristics, socio-economic status, MDA drug uptake among themselves and their children, reasons for taking/not taking drugs, and participation in previous MDA activities for LF control. Findings The overall drug uptake rate was 55.1% (range of 44.5–75.6% between districts). There was no overall major difference between children (54.8%) and adults (55.2%) or between females (54.9%) and males (55.8%), but the role of these and other predictors varied to some extent between study sites. Major overall predictors of drug uptake among the interviewed adults were increasing age and history of previous drug uptake. Being absent from home during drug distribution was the main reason for not taking the drugs (50.2%) followed by clinical contraindications to treatment (10.8%), missing household visits of drug distributors (10.6%), and households not being informed about the distribution (9.0%). Conclusion Drug uptake relied more on easily modifiable provider-related factors than on individual perceptions and practices in the target population. Limited investments in appropriate timing, dissemination of accurate timing information to recipients and motivation of drug distributors to visit all households (repeatedly when residents are absent) are likely to have

  3. Current Status of Mechanical Circulatory Support: A Systematic Review

    PubMed Central

    Spiliopoulos, Kyriakos; Giamouzis, Gregory; Karayannis, George; Karangelis, Dimos; Koutsias, Stelios; Kalogeropoulos, Andreas; Georgiopoulou, Vasiliki; Skoularigis, John; Butler, Javed; Triposkiadis, Filippos

    2012-01-01

    Heart failure is a major public health problem and its management requires a significant amount of health care resources. Even with administration of the best available medical treatment, the mortality associated with the disease remains high. As therapeutical strategies for heart failure have been refined, the number of patients suffering from the disease has expanded dramatically. Although heart transplantation still represents the gold standard therapeutical approach, the implantation of mechanical circulatory support devices (MCSDs) evolved to a well-established management for this disease. The limited applicability of heart transplantation caused by a shortage of donor organs and the concurrent expand of the patient population with end-stage heart failure led to a considerable utilization of MCSDs. This paper outlines the current status of mechanical circulatory support. PMID:22970403

  4. Safeguarding the process of drug administration with an emphasis on electronic support tools

    PubMed Central

    Seidling, Hanna M; Lampert, Anette; Lohmann, Kristina; Schiele, Julia T; Send, Alexander J F; Witticke, Diana; Haefeli, Walter E

    2013-01-01

    Aims The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. Methods To identify a generic way to structure the drug administration process we performed peer-group discussions and supplemented these discussions with a literature search for studies reporting errors in drug administration and strategies for their prevention. Results We concluded that the drug administration process might consist of up to 11 sub-steps, which can be grouped into the four sub-processes of preparation, personalization, application and follow-up. Errors in drug handling and administration are diverse and frequent and in many cases not caused by the patient him/herself, but by family members or nurses. Accordingly, different prevention strategies have been set in place with relatively few approaches involving e-health technology. Conclusions A generic structuring of the administration process and particular error-prone sub-steps may facilitate the allocation of prevention strategies and help to identify research gaps. PMID:24007450

  5. Elimination and Eradication of Neglected Tropical Diseases with Mass Drug Administrations: A Survey of Experts

    PubMed Central

    Keenan, Jeremy D.; Hotez, Peter J.; Amza, Abdou; Stoller, Nicole E.; Gaynor, Bruce D.; Porco, Travis C.; Lietman, Thomas M.

    2013-01-01

    Background Lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminths, and trachoma are the five most prevalent neglected tropical diseases in the world, and each is frequently treated with mass drug administrations. We performed a survey of neglected tropical diseases experts to elicit their opinions on the role of mass drug administrations for the elimination of these infections. Methodology/Principal Findings We sent an online survey to corresponding authors who had published an article about a neglected tropical disease from 2007 to 2011. Of 825 unique authors who were invited to complete the survey, 365 (44.2%) responded, including 234 (28.4%) who answered questions regarding one of the five most prevalent neglected tropical diseases. Respondents had varying opinions about the goals of programmatic activities for their chosen neglected tropical disease, with elimination or eradication identified as the most important goal by 87% of lymphatic filariasis respondents, 66% of onchocerciasis respondents, 55% of trachoma respondents, 24% of schistosomiasis respondents, and 21% of soil-transmitted helminth respondents. Mass drug administrations, other non-medication health measures, and education were generally thought to be more important for elimination than vector control, development of a new tool, or the presence of a secular trend. Drug resistance was thought to be a major limitation of mass drug administrations for all five neglected tropical diseases. Over half of respondents for lymphatic filariasis and trachoma thought that repeated mass drug administrations could eliminate infection within ten years of the initiation of mass treatments. Conclusions/Significance Respondents for lymphatic filariasis, onchocerciasis, and trachoma were more enthusiastic about the prospects of elimination and eradication than were respondents for schistosomiasis or soil-transmitted helminths. Mass drug administrations were generally believed to be among

  6. Hemodynamics of Mechanical Circulatory Support.

    PubMed

    Burkhoff, Daniel; Sayer, Gabriel; Doshi, Darshan; Uriel, Nir

    2015-12-15

    An increasing number of devices can provide mechanical circulatory support (MCS) to patients with acute hemodynamic compromise and chronic end-stage heart failure. These devices work by different pumping mechanisms, have various flow capacities, are inserted by different techniques, and have different sites from which blood is withdrawn and returned to the body. These factors result in different primary hemodynamic effects and secondary responses of the body. However, these are not generally taken into account when choosing a device for a particular patient or while managing a patient undergoing MCS. In this review, we discuss fundamental principles of cardiac, vascular, and pump mechanics and illustrate how they provide a broad foundation for understanding the complex interactions between the heart, vasculature, and device, and how they may help guide future research to improve patient outcomes. PMID:26670067

  7. Comparison of a drug versus money and drug versus drug self-administration choice procedure with oxycodone and morphine in opioid addicts.

    PubMed

    Comer, Sandra D; Metz, Verena E; Cooper, Ziva D; Kowalczyk, William J; Jones, Jermaine D; Sullivan, Maria A; Manubay, Jeanne M; Vosburg, Suzanne K; Smith, Mary E; Peyser, Deena; Saccone, Phillip A

    2013-09-01

    This double-blind, placebo-controlled study investigated the effects of oral morphine (0, 45, 135 mg/70 kg) and oral oxycodone (0, 15, 45 mg/70 kg) on buprenorphine-maintained opioid addicts. As a 3: 1 morphine : oxycodone oral dose ratio yielded equivalent subjective and physiological effects in nondependent individuals, this ratio was used in the present study. Two self-administration laboratory procedures - that is, a drug versus money and a drug versus drug procedure - were assessed. Study participants (N=12) lived in the hospital and were maintained on 4 mg/day sublingual buprenorphine. When participants chose between drug and money, money was preferred over all drug doses; only high-dose oxycodone was self-administered more than placebo. When participants chose between drug and drug, both drugs were chosen more than placebo, high doses of each drug were chosen over low doses, and high-dose oxycodone was preferred over high-dose morphine. The subjective, performance-impairing, and miotic effects of high-dose oxycodone were generally greater than those of high-dose morphine. The study demonstrated that a 3: 1 oral dose ratio of morphine : oxycodone was not equipotent in buprenorphine-dependent individuals. Both self-administration procedures were effective for assessing the relative reinforcing effects of drugs; preference for one procedure should be driven by the specific research question of interest. PMID:23839029

  8. Comparison of a drug versus money and drug versus drug self-administration choice procedure with oxycodone and morphine in opioid addicts

    PubMed Central

    Comer, Sandra D; Metz, Verena E; Cooper, Ziva D; Kowalczyk, William J; Jones, Jermaine D; Sullivan, Maria A; Manubay, Jeanne M; Vosburg, Suzanne K; Smith, Mary E; Peyser, Deena; Saccone, Phillip A

    2014-01-01

    This double-blind, placebo-controlled study investigated effects of oral morphine (0, 45, 135 mg/70kg) and oral oxycodone (0, 15, 45 mg/70kg) in buprenorphine-maintained opioid addicts. Since a 3:1 morphine:oxycodone dose ratio had yielded equivalent subjective and physiological effects in non-dependent individuals, this ratio was used in the present study. Two self-administration laboratory procedures, i.e. a drug vs. money and a drug vs. drug procedure, were assessed. Study participants (N=12) lived in the hospital and were maintained on 4 mg/day sublingual buprenorphine. When participants chose between drug and money, money was preferred over all drug doses; only high-dose oxycodone was self-administered more than placebo. When participants chose between drug and drug, both drugs were chosen more than placebo, high doses of each drug were chosen over low doses, and high-dose oxycodone was preferred over high-dose morphine. The subjective, performance-impairing, and miotic effects of high-dose oxycodone were generally greater compared to high-dose morphine. The study demonstrated that a 3:1 dose ratio of morphine:oxycodone was not equipotent in buprenorphine-dependent subjects. Both self-administration procedures were effective for assessing the relative reinforcing effects of drugs; preference for one procedure should be driven by the specific research question of interest. PMID:23839029

  9. Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration.

    PubMed

    Sullivan, Helen W; Aikin, Kathryn J; Chung-Davies, Eunice; Wade, Michael

    2016-01-01

    The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources. PMID:27149513

  10. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

    PubMed

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

    Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years. PMID:25613202