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Sample records for drug administration advisory

  1. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  2. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

    PubMed

    Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

    2014-10-01

    Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

  3. Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.

    PubMed

    Lurie, Peter; Almeida, Cristina M; Stine, Nicholas; Stine, Alexander R; Wolfe, Sidney M

    2006-04-26

    In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings. To characterize financial conflict disclosures at drug-related meetings, and to assess the relationship between conflicts and voting behavior at meetings that considered specific products. Cross-sectional study using agendas and transcripts from all FDA Drug Advisory Committee meetings (2001-2004) listed on the FDA Web site. Conflict rates, type, and size. The relationship between having a conflict and voting in favor of the index drug was described for each voter using Mantel-Haenszel relative risks and Monte Carlo simulations; Spearman rho was used for a meeting-level analysis comparing rates of conflict with voting patterns. The impact of the removal of persons with conflicts of interest on the vote margins was also evaluated. A total of 221 meetings held by 16 advisory committees were included in the study. In 73% of the meetings, at least 1 advisory committee member or voting consultant disclosed a conflict; only 1% of advisory committee members were recused. For advisory committee members (n = 1957) and voting consultants combined (n = 990), 28% (n = 825) disclosed a conflict. The most commonly specified conflicts were consulting arrangements, contracts/grants, and investments. Nineteen percent of consulting arrangements involved over 10,000 dollars, 23% of contracts/grants exceeded 100,000 dollars, and 30% of investments were over 25,000 dollars. The meeting-level analysis did not show a statistically significant relationship between conflict rates ("index conflict," "competitor conflict," or "any conflict") and voting patterns, but a weak, statistically significant positive relationship was apparent for competitor conflict and any conflict in the Mantel-Haenszel analyses. The Monte Carlo analyses produced similar findings in the competitor conflict analysis only. In all 3

  4. Revocation of advisory opinion entitled "FD&C Act Trade Correspondence 61". Food and Drug Administration, HHS. Notice; revocation.

    PubMed

    1999-05-21

    The Food and Drug Administration (FDA) is revoking an advisory opinion entitled "FD&C Act Trade Correspondence, TC-61," (hereinafter called TC-61) dated February 15, 1940, because it is out of date with current scientific knowledge and is superseded by the final rule for over-the-counter (OTC) sunscreen drug products. As an advisory opinion, this correspondence was not published in the Federal Register.

  5. 75 FR 5333 - Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee scheduled for February 24, 2010, is cancelled. This...

  6. 75 FR 36101 - Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This...

  7. 77 FR 27072 - Gastrointestinal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 31, 2012, is canceled. This meeting was announced in...

  8. Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting regarding cangrelor.

    PubMed

    Lhermusier, Thibault; Baker, Nevin C; Waksman, Ron

    2015-04-15

    Landmark clinical trials have established the benefit of P2Y12 inhibitors in the setting of acute coronary syndrome and percutaneous coronary intervention. On February 12, 2014, the Medicines Company (Sponsor) presented efficacy and safety data regarding cangrelor to the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee. The Sponsor sought approval for 2 indications: (1) in the setting of percutaneous coronary intervention for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with coronary artery disease and (2) in the setting of bridging therapy in patients with acute coronary syndrome or with stents who are at increased risk for thrombotic events (such as stent thrombosis) when oral P2Y12 therapy is interrupted because of surgery. The following is a summary of the data presented to the FDA by the Sponsor, the FDA's clinical review of cangrelor.

  9. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee...

  10. Trends in Bone Morphogenetic Protein Usage since the U.S. Food and Drug Administration Advisory in 2008: What Happens to Physician Practices When the Food and Drug Administration Issues an Advisory?

    PubMed

    Mckie, Janay; Qureshi, Sheeraz; Iatridis, James; Egorova, Natalia; Cho, Samuel; Hecht, Andrew

    2014-06-01

    Study Design Retrospective cross-sectional study of spinal procedures from 2002 to 2010 using the Nationwide Inpatient Sample database. Objective To determine the patterns of bone morphogenetic protein (BMP) usage in fusion surgery before and after the U.S. Food and Drug Administration (FDA) 2008 advisory for the anterior cervical spine to understand how advisories affect U.S. physician practices. Methods Procedures were identified through International Classification of Diseases, Ninth Revision procedure codes and were plotted over time based on fusion procedure type, site, and area of fusion. U.S. national trends were approximated by polynomial regression analysis. Results The majority of the data trends of BMP usage reflect a second-order polynomial model. BMP usage in anterior cervical spine fusion procedures plateaued during the fourth quarter of 2007. The most apparent change in trend was noted in BMP usage pre- and postadvisory in the analysis of anterior cervical spine fusions. BMP percentage of use decreased in this area by 5% from the time of the FDA advisory to the fourth quarter of 2010. Conclusions The decrease in BMP usage in anterior cervical spinal fusion procedures coincided with the timing of the FDA advisory. The fact that BMP continued to be used in cervical spine fusion procedures, even at lower rates, despite the advisory, may reflect the availability of new clinical information that could lessen complications (i.e., lower BMP dose, perioperative steroids, BMP containment). Furthermore, factors like the natural ceiling effect of use or demand for new technology, complications, prohibitive institutional costs, access to information, and insurance compensation may have all contributed to the BMP usage trends observed.

  11. Trends in Bone Morphogenetic Protein Usage since the U.S. Food and Drug Administration Advisory in 2008: What Happens to Physician Practices When the Food and Drug Administration Issues an Advisory?

    PubMed Central

    Mckie, Janay; Qureshi, Sheeraz; Iatridis, James; Egorova, Natalia; Cho, Samuel; Hecht, Andrew

    2013-01-01

    Study Design Retrospective cross-sectional study of spinal procedures from 2002 to 2010 using the Nationwide Inpatient Sample database. Objective To determine the patterns of bone morphogenetic protein (BMP) usage in fusion surgery before and after the U.S. Food and Drug Administration (FDA) 2008 advisory for the anterior cervical spine to understand how advisories affect U.S. physician practices. Methods Procedures were identified through International Classification of Diseases, Ninth Revision procedure codes and were plotted over time based on fusion procedure type, site, and area of fusion. U.S. national trends were approximated by polynomial regression analysis. Results The majority of the data trends of BMP usage reflect a second-order polynomial model. BMP usage in anterior cervical spine fusion procedures plateaued during the fourth quarter of 2007. The most apparent change in trend was noted in BMP usage pre- and postadvisory in the analysis of anterior cervical spine fusions. BMP percentage of use decreased in this area by 5% from the time of the FDA advisory to the fourth quarter of 2010. Conclusions The decrease in BMP usage in anterior cervical spinal fusion procedures coincided with the timing of the FDA advisory. The fact that BMP continued to be used in cervical spine fusion procedures, even at lower rates, despite the advisory, may reflect the availability of new clinical information that could lessen complications (i.e., lower BMP dose, perioperative steroids, BMP containment). Furthermore, factors like the natural ceiling effect of use or demand for new technology, complications, prohibitive institutional costs, access to information, and insurance compensation may have all contributed to the BMP usage trends observed. PMID:25072000

  12. 75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee....

  13. 77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Oncologic Drugs Advisory Committee. This meeting...

  14. 76 FR 65736 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  15. 77 FR 17078 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  16. 75 FR 47309 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  17. 76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  18. 77 FR 37414 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  19. 76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  20. 76 FR 32220 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  1. 77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  2. 78 FR 13349 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be...

  3. 78 FR 37820 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... HUMAN SERVICES Food and Drug Administration Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  4. 76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  5. 75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... HUMAN SERVICES Food and Drug Administration Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  6. 78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  7. 77 FR 7587 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of...

  8. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  9. 78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-17

    ... HUMAN SERVICES Food and Drug Administration Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  10. 77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  11. 75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  12. 75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  13. 77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  14. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  15. 76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the...

  16. 77 FR 49446 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to...

  17. 76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... HUMAN SERVICES Food and Drug Administration Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the...

  18. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... committee have been resolved. FOR FURTHER INFORMATION CONTACT: Caleb Briggs, Center for Drug Evaluation...

  19. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for September 14, 2012, is cancelled. The meeting...

  20. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a...

  1. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function... primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure...

  2. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. ] Name of Committee: Cardiovascular and Renal Drugs Advisory Committee....

  3. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... Committee; Medical Imaging Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION... on the Medical Imaging Drugs Advisory Committee in the Center for Drug Evaluation and Research. FDA... requesting nominations for voting members on the Medical Imaging Drugs Advisory Committee (the Committee...

  4. 77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ...] [FR Doc No: 2012-12588] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of...

  5. 77 FR 52743 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... support new drug application (NDA) 202211, for the partial switch from prescription to over-the-counter... HUMAN SERVICES Food and Drug Administration Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of...

  6. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Arthritis Drugs Advisory Committee and...: Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General...

  7. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of..., Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of the Committee: To provide...

  8. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  9. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for...

  10. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for...

  11. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for...

  12. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice..., 2012, Drug Safety and Risk Management Advisory Committee meeting due to unanticipated weather conditions caused by Hurricane Sandy. Name of Committee: Drug Safety and Risk Management Advisory Committee...

  13. 78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA...

  14. 77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will...

  15. 76 FR 23324 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-26

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will...

  16. 77 FR 49447 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will...

  17. 75 FR 32188 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting...

  18. 77 FR 16038 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting...

  19. Food and Drug Administration

    MedlinePlus

    ... Reportable Food Registry Report an Emergency Report Suspected Criminal Activity For Industry: Drugs and Therapeutic Biologics News & ... FDA Organization FDA Basics Advisory Committees International Programs Criminal Investigations Emergency Preparedness & Response Working at FDA Training/ ...

  20. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Arthritis Advisory Committee and the... to the notice of a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk... meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee...

  1. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Amendment of... Administration (FDA) is announcing an amendment to the notice of a meeting of the Pulmonary-Allergy Drugs... meeting of the Pulmonary-Allergy Drugs Advisory Committee would be held on March 10 and 11, 2010. On...

  2. 77 FR 48992 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

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

  3. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products...

  4. 75 FR 81618 - Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... HUMAN SERVICES Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Anesthetic and Life Support Drugs Advisory Committee... degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results...

  5. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management...

  6. Trends in Mode of Hysterectomy After the U.S. Food and Drug Administration Power Morcellation Advisory.

    PubMed

    Ottarsdottir, Helga; Cohen, Sarah L; Cox, Mary; Vitonis, Allison; Einarsson, Jon I

    2017-06-01

    To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines. This is a retrospective review of all patients who underwent a hysterectomy for benign indications, specifically for leiomyomas, at Brigham and Women's Hospital from 2013 to 2015. The rates of abdominal, vaginal, laparoscopic, and robotic-assisted laparoscopic hysterectomy as well as the perioperative outcomes were compared over the study period. Analysis was performed using multivariable linear, multinomial, and logistic regression. Regression models were adjusted for potential confounders. From 2013 to 2015, 1,530 patients underwent a hysterectomy for benign indications and 639 patients underwent the procedure for the indication of uterine leiomyomas; there was a decrease in the number of hysterectomy cases in the later years. Focusing on the patients with leiomyomas alone, there was a 40-60% decreased odds of a minimally invasive procedure in 2014 or 2015 compared with 2013 [adjusted odds ratio (OR) 0.53 (0.29-0.97) in 2014 and adjusted OR 0.40 (0.22-0.74) in 2015, P=.003]. A 24% decrease in the supracervical approach to hysterectomy was also noted. Despite these trends, the majority of cases in each year were still performed in a minimally invasive fashion. The factor most strongly associated with undergoing a minimally invasive hysterectomy was having a fellowship-trained surgeon perform the procedure [adjusted OR 6.80 (3.65-12.7), P<.001]. There was no significant difference between the year of surgery and occurrence of intraoperative complications or reoperation. Although key perioperative outcomes remained similar, the overall rate of minimally invasive surgery declined at our institution after the FDA's recommendations. With changing practice patterns and vigilance surrounding power morcellation, gynecologic surgeons may still offer patients minimally invasive procedures with all of the accompanying advantages.

  7. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Advisory Committee for Reproductive... of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... break loose and move within the circulatory system) associated with use of these products may be...

  8. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  9. 77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  10. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  11. 75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  12. 77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  13. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  14. 78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  15. 77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of... to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of...

  16. 75 FR 39032 - Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES> Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee... be open to the public. Name of Committee: Anesthetic and Life Support Drugs Advisory...

  17. 77 FR 67380 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory...

  18. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  19. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  20. 75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  1. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  2. 75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General...

  3. 75 FR 26264 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  4. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...

  5. 76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Reproductive Health Drugs; Notice of... to the public. Name of Committee: Advisory Committee for Reproductive Health Drugs. General...

  6. 78 FR 29142 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory Committee...

  7. 76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are... HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...

  8. 77 FR 8262 - Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug... portion of the meeting (Topic 2), relating to the appropriateness of marketing a single bottle of...

  9. Drug Education for Administrators

    ERIC Educational Resources Information Center

    Hackett, Peter; McKeon, Thomas L.

    1976-01-01

    The formulation of a drug policy and the implementation of that policy in a firm but fair manner are the responsibility of the school administrator. Authors give serious consideration to this responsibility. (Editor/RK)

  10. 77 FR 69869 - National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... HUMAN SERVICES National Institutes of Health National Advisory Council on Alcohol Abuse and Alcoholism... hereby given of a joint teleconference and Web cast meeting of the National Advisory Council on Alcohol... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board...

  11. 75 FR 876 - Anesthetic and Life Support Drugs Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the...

  12. 78 FR 42088 - Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Anesthetic...

  13. 75 FR 59730 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... public. Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

  14. 75 FR 12767 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... public. Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

  15. 75 FR 67093 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... will be closed to the public. Name of Committees: Anesthetic and Life Support Drugs Advisory Committee...

  16. 77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  17. 75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  18. 75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory...). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs...

  19. 75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Cardiovascular and Renal Drugs...

  20. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ... HUMAN SERVICES Food and Drug Administration Medical Imaging Drugs Advisory Committee; Notice of Meeting... resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood...

  1. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current... FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation and Research, Food and Drug..., Radiation protection. Therefore, under the Federal Food, Drug, and Cosmetic Act and under...

  2. Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.

    PubMed

    Steinvil, Arie; Rogers, Toby; Torguson, Rebecca; Waksman, Ron

    2016-09-12

    This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. Following panel discussions and the evidence presented, the panel voted for approval of the device. Copyright © 2016 American College of Cardiology Foundation

  3. 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…

  4. 76 FR 36930 - National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... HUMAN SERVICES National Institutes of Health National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant to section 10(d) of the... the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse...

  5. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Veterinary Medicine... Food and Drug Administration (FDA) is announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of...

  6. 76 FR 54777 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-02

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations...

  7. 75 FR 47523 - Assembly of the Administrative Conference; Filing of Advisory Committee Charter

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...; ] ADMINISTRATIVE CONFERENCE OF THE UNITED STATES Assembly of the Administrative Conference; Filing of Advisory Committee Charter AGENCY: Administrative Conference of the United States. ACTION: Notice. SUMMARY: Notice is hereby given that the Administrative Conference of the United States will file an advisory...

  8. Transparency in Canadian public drug advisory committees.

    PubMed

    Rosenberg-Yunger, Zahava R S; Bayoumi, Ahmed M

    2014-11-01

    Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached. We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence. Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  9. Overview of the 2011 food and drug administration's circulatory system devices panel of the medical devices advisory committee meeting on the Zilver® PTX® drug-eluting peripheral stent.

    PubMed

    Dvir, Danny; Torguson, Rebecca; Waksman, Ron

    2012-01-01

    Zilver® PTX® (Cook Medical, Bloomington, IN) is a self-expanding nitinol drug-eluting stent with a polymer-free paclitaxel coating on its outer surface. The stent aims to provide improved treatment for patients with symptomatic peripheral arterial disease in the above-the-knee femoropopliteal arteries. On October 13, 2011, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Zilver PTX premarket approval application. This summary aims to describe the discussions and recommendations made during the meeting. Based on the Panel's recommendations, it is anticipated that the device will be approved by the FDA. Copyright © 2012. Published by Elsevier Inc.

  10. 77 FR 20643 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... following links. Blood Products Advisory Committee Web Cast Link May 15...

  11. 76 FR 39405 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... available at the following links. Blood Products Advisory Committee Day 1:...

  12. 76 FR 12793 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC).The... electronic tax administration issues in support of the overriding goal that paperless filing should be the...

  13. 75 FR 30109 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The... electronic tax administration issues in support of the overriding goal that paperless filing should be the...

  14. 75 FR 71188 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The... electronic tax administration issues in support of the overriding goal that paperless filing should be the...

  15. 78 FR 32306 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-29

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Electronic Tax Administration Advisory Committee (ETAAC) will be conducted via telephone conference call. The ETAAC will discuss recommendations for electronic tax administration which will be published in the...

  16. 78 FR 38042 - The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... ADMINISTRATION The Presidential Commission on Election Administration (PCEA); Upcoming Public Advisory Meeting...: Meeting notice; correction. SUMMARY: The Presidential Commission on Election Administration (PCEA), is... CONTACT: Mr. Mark Nejbauer, Designated Federal Officer, President's Commission on Election...

  17. 75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ... [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of the Committee:...

  18. 77 FR 31441 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-25

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC).The primary purpose of ETAAC is to provide an organized public forum for discussion of electronic tax...

  19. 77 FR 70879 - Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... Internal Revenue Service Open Meeting for the Electronic Tax Administration Advisory Committee (ETAAC... Internal Revenue Service established the Electronic Tax Administration Advisory Committee (ETAAC). The primary purpose of ETAAC is to provide an organized public forum for discussion of electronic tax...

  20. [Drug administration to paediatric inpatient].

    PubMed

    Fontan, J E; Mille, F; Brion, F; Aubin, F; Ballereau, F; Benoît, G; Brunet, M L; Braguier, D; Combeau, D; Dugast, P; Gérout, A C; May, I; Meunier, P; Naveau-Ploux, C; Proust, V; Samdjee, F; Schlatter, J; Thébault, A; Vié, M

    2004-10-01

    Available commercial drugs in France are often unsuitable for children. The aim of this study was, for every medicinal form orally or parenterally administered, to identify and to quantify difficulties met by the nurses administering drugs to paediatric inpatients and to propose solutions to main identified problems. The study was realized in 14 hospitals by direct observation. The observer, provided with a questionnaire, followed during a time slot of at least 2 h for one or several nurses and raised all the oral or injectable administrations. One thousand and nine hundred forty-six observations were performed. The children were 12.6 +/- 17 months old, and weighed 8.5 +/- 9.4 kg. Injectable drugs: half of the observations showed a posology and a mode of dilution not corresponding to the summary of product characteristics. Eight percent of orally administered drugs were injectable drugs. In 35.5% of cases, administered amount was lower than the quarter of the present quantity in the therapeutic unity. The rest of the therapeutic unity was thrown (77.2% of cases). Liquid oral forms: liquid oral forms were ready for use regarding 83.8% of cases. The medicine was readministered to the same patient (23.5%), and/or administered to other patients (80.0%). Capsules: 66.9% of the administered capsules were prepared by the hospital pharmacies. The pharmacies organized with an unit dose drug dispensing system produced significantly more preparations than those working by global distribution (P < 0.0001). In 58.4% of cases, the administered capsule was an off-label drug. Tablets: 46% of drug administration concerned a tablet without pediatric indication. 46.7% of tablets were cut, 74% were crushed. Bags: in 35.2% of observations, the bag was not administered in its entirety. Our study confirms the unsuitability of drugs to paediatric inpatients, the necessity of recommendations of good practices in the administration of drugs to paediatric inpatients, and proposes corrective

  1. The National Shipbuilding Research Program. Occupational Safety & Health Administration (OSHA) Technical Advisory Committee

    DTIC Science & Technology

    2000-12-29

    0576 N5-97-3 Occupational Safety & Health Administration (OSHA) Technical Advisory Committee U.S. DEPARTMENT OF THE NAVY CARDEROCK DIVISION, NAVAL...4. TITLE AND SUBTITLE The National Shipbuilding Research Program, Occupational Safety & Health Administration (OSHA) Technical Support

  2. 76 FR 37131 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and... and Risk Management Advisory Committee. General Function of the Committees: To provide advice and...

  3. 76 FR 38667 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory Committee... be open to the public. Name of Committee: Transmissible Spongiform Encephalopathies Advisory... available at the following link. Transmissible Spongiform Encephalopathies Advisory Committee http://fda...

  4. 75 FR 76993 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  5. 75 FR 56547 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  6. 77 FR 31025 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ...-2012-N-0001] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Risk Communication Advisory Committee. General Function of the Committee: To provide advice and...: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration,...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative: Food...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. SUMMARY: As part of the Transparency Initiative, the Food and Drug Administration (FDA or Agency) is...

  8. 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

  9. Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews.

    PubMed

    Chan, John K; Kiet, Tuyen K; Monk, Bradley J; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S; Amanam, Idoroenyi

    2014-03-01

    Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. All applications referred to the ODAC from 2001 to 2012 were reviewed. Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001-2004, 2005-2008, 2009-2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs.

  10. 78 FR 56900 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ...: Karen Abraham-Burrell, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New... you require special accommodations due to a disability, please contact Karen Abraham- Burrell at least...

  11. 78 FR 44132 - Food Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... HUMAN SERVICES Food and Drug Administration Food Advisory Committee; Notice of Meeting AGENCY: Food and... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food Advisory Committee. General Function of the Committee: To provide advice and...

  12. 75 FR 74735 - Food Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... HUMAN SERVICES Food and Drug Administration Food Advisory Committee; Notice of Meeting AGENCY: Food and... advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food Advisory Committee. General Function of the Committee: To provide advice and...

  13. 76 FR 80952 - Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... epidemiology, pediatric development, and analytical chemistry or food science to serve on the Food Advisory... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  14. 75 FR 24773 - Research and Innovative Technology Administration Advisory Council on Transportation Statistics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Bureau of Transportation Statistics Research and Innovative Technology Administration Advisory Council on Transportation Statistics; Notice of Meeting AGENCY: Research and Innovative Technology Administration, U.S. Department of Transportation....

  15. 78 FR 69133 - Drug Enforcement Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... 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 the following basic classes of controlled substances: Drug Schedule Tetrahydrocannabinols (7370) I...

  16. 76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... November 18, 2011, the committee will discuss implications, for strategic communication, of...

  17. 75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... and lessons from a selection of the FDA's previously issued communications, emphasizing...

  18. 78 FR 17414 - Risk Communications Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-21

    ... HUMAN SERVICES Food and Drug Administration Risk Communications Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communications Advisory Committee. General Function of the...: Luis G. Bravo, Designated Federal Officer, Risk Communication Staff, Office of Planning, Food and...

  19. 76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... work, as discussed in previous meetings, by current and former members of the Risk...

  20. 77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... Campus must enter through Building 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff,...

  1. 76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the...

  2. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Standards advisory committees. 861.38 Section 861.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  3. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Standards advisory committees. 861.38 Section 861.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  4. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Standards advisory committees. 861.38 Section 861.38 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. SUMMARY:...

  6. Aerospace Safety Advisory Panel report to the NASA acting administrator

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The level of activity of the Aerospace Safety Advisory Panel was increased smewhat during 1985 in concert with the increased mission rate of the National Space Transportation System, the evolutionary changes in management and operation of that program, and the preparation of the Vandenberg Launch Site; the implementation of the Program Definition Phase of the Space Station Program; and the actual flight testing of the X-29 research aircraft. Impending payload STS missions and NASA's overall aircraft operations are reviewed. The safety aspects of the LEASAT salvage mission were assessed. The findings and recommendation of the committee are summerized.

  7. Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System.

    PubMed

    Loh, Joshua P; Barbash, Israel M; Waksman, Ron

    2013-04-16

    The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.

  8. 75 FR 16148 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the... acute malaria who cannot take medication by mouth and for whom injectable treatment is not available...

  9. 76 FR 25359 - Science Board Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

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

  10. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Standards advisory committees. 861.38 Section 861... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will..., Food and Drug Administration. (d) Where appropriate, each proposed regulation establishing a standard...

  11. An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

    PubMed

    Chua, S S; Tea, M H; Rahman, M H A

    2009-04-01

    Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

  12. Adverse Drug Event Monitoring at the Food and Drug Administration

    PubMed Central

    Ahmad, Syed Rizwanuddin

    2003-01-01

    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk. PMID:12534765

  13. Adverse drug event monitoring at the Food and Drug Administration.

    PubMed

    Ahmad, Syed Rizwanuddin

    2003-01-01

    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk.

  14. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond... . Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data...

  15. [Innovative therapeutic strategies for intravesical drug administration].

    PubMed

    Moch, C; Salmon, D; Rome, P; Marginean, R; Pivot, C; Colombel, M; Pirot, F

    2013-05-01

    Perspectives for innovative pharmaceutical molecules and intravesical administration of pharmacological agents are presented in the present review carried out from a recent literature. This review of the literature was built by using the PubMed and ScienceDirect databases running 20keywords revealing 34publications between 1983 and 2012. The number of referenced articles on ScienceDirect has increased in recent years, highlighting the interest of scientists for intravesical drug administration and the relevance of innovating drug delivery systems. Different modalities of intravesical administration using physical (e.g., iontophoresis, electroporation) or chemical techniques (e.g., enzyme, solvent, nanoparticles, liposomes, hydrogels) based on novel formulation methods are reported. Finally, the development of biopharmaceuticals (e.g., bacillus Calmette-Guérin, interferon α) and gene therapies is also presented and analyzed in this review. The present review exhibits new development in the pipeline for emerging intravesical drug administration strategies. Knowledge of all these therapies allows practitioners to propose a specific and tailored treatment to each patient with limiting systemic side effects. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  16. 76 FR 60848 - National Mammography Quality Assurance Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... HUMAN SERVICES Food and Drug Administration National Mammography Quality Assurance Advisory Committee... be open to the public. Name of Committee: National Mammography Quality Assurance Advisory Committee...) Proposed changes to the Mammography Quality Standard Act (MQSA) policies and inspection procedures;...

  17. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Device Good Manufacturing Practice Advisory Committee... meeting will be open to the public. Name of Committee: Device Good Manufacturing Practice Advisory... effects of extreme weather and natural disasters on medical device manufacturing chain processes...

  18. 78 FR 11207 - Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory Committee... be open to the public. Name of Committee: Transmissible Spongiform Encephalopathies Advisory...

  19. 77 FR 10755 - Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for members to serve...

  20. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the Risk Communication Advisory Committee. This meeting... announced that a meeting of the Risk Communication Advisory Committee would be held on November 8 and...

  1. 75 FR 35494 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... Services Advisory Committee on Blood Safety and Availability; December 14 and 15, 2009, FDA workshop...

  2. 77 FR 4567 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To..., the meeting will also be Web cast. The Blood Products Advisory Committee Web cast will be available...

  3. 78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Risk Communications Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communications Advisory Committee. General Function of the... the free Webcast. Visit the Risk Communication Advisory Committee Web site at http://www.fda.gov...

  4. 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...

  5. 78 FR 78368 - Allergenic Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

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

  6. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... HUMAN SERVICES Food and Drug Administration Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  7. 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...

  8. 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 Drug...

  9. 21 CFR 14.86 - Rights and responsibilities of nonvoting members of advisory committees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of advisory committees. 14.86 Section 14.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Advisory Committees § 14.86 Rights and responsibilities of nonvoting members of advisory committees. (a) A... meeting dates; (2) A nonvoting member who is a representative of industry interest may have access to data...

  10. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Disclosure to consultants, advisory committees... consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local...

  11. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Disclosure to consultants, advisory committees... consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local...

  12. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Disclosure to consultants, advisory committees... consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local...

  13. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Disclosure to consultants, advisory committees... consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local...

  14. 21 CFR 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Disclosure to consultants, advisory committees... consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372... disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local...

  15. 77 FR 47078 - 2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... HUMAN SERVICES Food and Drug Administration 2012 Parenteral Drug Association/Food and Drug... Sustainable Global Quality Culture AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with Parenteral Drug...

  16. 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.

  17. 21 CFR 14.22 - Meetings of an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Meetings of an advisory committee. 14.22 Section 14.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL..., e.g., the Board of Tea Experts and the Science Advisory Board of the National Center...

  18. 21 CFR 14.22 - Meetings of an advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Meetings of an advisory committee. 14.22 Section 14.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL..., e.g., the Science Advisory Board of the National Center for Toxicological Research will...

  19. School Administrator Supply and Demand for the State of Maine. A Study Conducted for the Department of Educational and Cultural Services Advisory Committee on Administrator Supply and Demand.

    ERIC Educational Resources Information Center

    Johnson, Judith L.

    The future supply and demand for Maine school administrators is assessed. Based on discussions with the Advisory Committee on Administrator Supply and Demand, a series of premises were established for the study. Survey instruments were designed, coded, and mailed to all superintendents and elementary and secondary principals in the state. A high…

  20. THE AGRICULTURAL ADVISORY BOARD, A HANDBOOK FOR BOARDS OF EDUCATION, SCHOOL ADMINISTRATORS ADVISORY BOARD MEMBERS AND TEACHERS OF AGRICULTURE.

    ERIC Educational Resources Information Center

    CUSHMAN, HAROLD R.

    THE PURPOSE OF THIS HANDBOOK IS TO ASSIST EDUCATIONAL PERSONNEL IN MAKING THE MOST EFFECTIVE USE OF AGRICULTURAL ADVISORY BOARDS IN THE ORGANIZATION AND DEVELOPMENT OF LOCAL VOCATIONAL AGRICULTURE PROGRAMS. IT CONTAINS INFORMATION ON (1) PROCEDURES FOR FORMING NEW AGRICULTURAL ADVISORY BOARDS OR REORGANIZING OLD ONES INCLUDING WHERE TO START, WHO…

  1. 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...

  2. 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...

  3. 76 FR 35451 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... refractory (resistant to previous standard treatments) Hodgkin's lymphoma. During the afternoon session, the... provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting.... Therefore, you should always check the Agency's Web site and call the appropriate advisory committee hot...

  4. 77 FR 13131 - Advisory Committees; Filing of Closed Meeting Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ... Research Allergenic Products Advisory Committee Blood Products Advisory Committee Cellular, Tissue and Gene Therapies Advisory Committee Vaccines and Related Biological Products Advisory Committee Center for Drug...

  5. 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

  6. 21 CFR 861.38 - Standards advisory committees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Development and Publication § 861.38 Standards advisory committees. (a) The Food and Drug Administration will... the proposed regulation which requires the exercise of scientific judgment if: (1) The Food and Drug...

  7. Exploring network theory for mass drug administration.

    PubMed

    Chami, Goylette F; Molyneux, David H; Kontoleon, Andreas A; Dunne, David W

    2013-08-01

    Network theory is a well-established discipline that uses mathematical graphs to describe biological, physical, and social systems. The topologies across empirical networks display strikingly similar organizational properties. In particular, the characteristics of these networks allow computational analysis to contribute data unattainable from examining individual components in isolation. However, the interdisciplinary and quantitative nature of network analysis has yet to be exploited by public health initiatives to distribute preventive chemotherapies. One notable application is the 2012 World Health Organization (WHO) Roadmap for Neglected Tropical Diseases (NTDs) where there is a need to upscale distribution capacity and to target systematic noncompliers. An understanding of local networks for analysing the distributional properties of community-directed treatment may facilitate sustainable expansion of mass drug-administration (MDA) programs.

  8. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... this meeting. Submit electronic comments to http://www.regulations.gov . Submit written comments to the... accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm ; under the heading ``Resources for You... potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an...

  9. [Suggestions on improving administration of local crude drug quality standards].

    PubMed

    Zhao, Yu-Xin; Ma, Guang-Lin; Yu, Jiang-Yong

    2017-07-01

    To improve the administration of local crude drug quality standard, the administration history, and current administration situation of local crude drugs were reviewed, the legal orientation and positive effect of local crude drugs were analyzed, and the existing problems were summarized. It was found that many problems existed in the administration of local crude drug quality standards, especially the phenomenon of homonym and synonym on their names. The suggestions on improving the administration of local crude drug quality standards were proposed. First of all, the construction of legal system should be strengthened to improve the administration methods. Secondly, the coordination mechanism should be developed to solve the outstanding problems. Thirdly, the basic research should be enhanced to resolve the general technical problems. Lastly, the channels to transfer the local crude drugs into pharmacopeia standards should be developed to achieve dynamic administration. Copyright© by the Chinese Pharmaceutical Association.

  10. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any...

  11. 78 FR 40144 - Governmentwide Travel Advisory Committee (GTAC); Upcoming Public Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... ADMINISTRATION Governmentwide Travel Advisory Committee (GTAC); Upcoming Public Advisory Committee Meeting AGENCY... Governmentwide Travel Advisory Committee (GTAC) (the Committee), is a Federal Advisory Committee established in..., Designated Federal Officer (DFO), Governmentwide Travel Advisory Committee (GTAC), Office of...

  12. 75 FR 22145 - Health Resources and Services Administration (HRSA); CDC/HRSA Advisory Committee on HIV and STD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... (HRSA); CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment (CHACHSPT) In accordance... the Administrator, HRSA, regarding activities related to the prevention and control of HIV/AIDS and other STDs, the support of healthcare services to persons living with HIV/AIDS, and the education...

  13. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery 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 public advisory committee of the Food and Drug...

  14. 76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of February 7, 2011... meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee would be held on...

  15. 75 FR 58414 - Dental Products Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of June 11, 2010... announced that a meeting of the Dental Products Panel of the Medical Devices Advisory Committee would...

  16. 77 FR 61007 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-05

    ... Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration... voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and...

  17. 78 FR 64505 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration... voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and...

  18. 77 FR 6567 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31... preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity....

  19. 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...

  20. 78 FR 20927 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,...

  1. 76 FR 10609 - Tobacco Products Scientific Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Amendment of...) is announcing an amendment to the notice of a meeting of the Tobacco Products Scientific Advisory..., Office of Science, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  2. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology 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 public advisory committee of the Food...

  3. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS... Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April...

  4. 76 FR 6626 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd...

  5. 75 FR 57967 - Science Advisory Board to the National Center for Toxicological Research Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory Board...

  6. 77 FR 57569 - Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-18

    ... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice... least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory...

  7. [Anatomophysiological bases of drug administration. Dosage forms and routes of administration].

    PubMed

    Carillo Norte, Juan Antonio; Gañán Presmanes, Yolanda

    2010-12-01

    The administration of the right dose to the right patient is of paramount importance to obtain an optimal drug response within the scope of clinical pharmacology and tailored medicine. The marketing of safer and more efficient drug entities, along with the development of new drug administration devices provide a major boost for the diagnosis and treatment of diseases, beyond our imagination. However dose adjustment is not enough to produced the desired effect, and drug therapy should include an appropriate route of drug administration. Currently, there are many different and sophisticated methods to incorporate drugs into the patients that nurses should be familiar with. When there is no contraindication, oral route of drug administration is of choice and most frequently used as a physiological pathway of drug intake.

  8. 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

    ... 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.'' This... Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act'' to the Division...

  9. Advisory Committee Report on Drug Abuse: Summations and Recommendations.

    ERIC Educational Resources Information Center

    Governor's Citizen Advisory Committee on Drugs, Salt Lake City, UT.

    A citizen's Drug Abuse Evaluation Committee was formed in Utah to evaluate past research and gather new data on basic questions concerning the drug problem. This booklet provides information based on the Committee's research, hearings, and an investigation of the current drug abuse problem in Utah. Data was also obtained from recorded testimony of…

  10. A review of human drug self-administration procedures

    PubMed Central

    Jones, Jermaine D.; Comer, Sandra D.

    2014-01-01

    Drug self-administration procedures in laboratory settings allow us to closely model drug-taking behavior in real-world settings. This review provides an overview of many of the common self-administration methods used in human laboratory research. Typically, self-administration studies provide a quantifiable measure of the reinforcing effect of a drug, which is believed to be predictive of its potential for abuse. Several adaptations of the self-administration paradigm exist, the simplest of which allows participants free access to the drug under investigation. Free-access procedures allow investigators to observe patterns of drug self-administration and drug effects in a controlled setting. Allowing participants to choose between two simultaneously available reinforcers (choice procedures) is another well-established method of assessing the reinforcing effects of a drug. Offering a choice between two reinforcers (e.g. two different doses of the same drug, two different drugs, or drug and nondrug reinforcers) provides researchers with a point of comparison (e.g. between a drug of known abuse potential and a novel drug). When combined with other endpoints, such as subjective effects ratings, physiological responses, and cognitive performance, human self-administration paradigms have contributed significantly to our understanding of the factors that contribute to, maintain, and alter drug-taking behavior including: craving, positive subjective effects, toxicity, drug interactions and abstinence. This area of research has also begun to incorporate other techniques such as imaging and genetics to further understand the multifaceted nature of substance abuse. The present paper summarizes the different self-administration techniques that are commonly used today and the application of other procedures that may complement interpretation of the drug PMID:23839027

  11. Animal models of social contact and drug self-administration.

    PubMed

    Strickland, Justin C; Smith, Mark A

    2015-09-01

    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.

  12. 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

    ... good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation... HUMAN SERVICES Food and Drug Administration Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and...

  13. 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

    ...; Demystifying Food and Drug Administration: An Exploration of Drug Development Hosted by the Food and Drug... registration fee for this conference. Early registration is suggested because space is limited. The...

  14. [Inhalation route for administration of systemic drugs].

    PubMed

    Mallet, J P; Diot, P; Lemarié, E

    1997-09-01

    With aerosolized administration of medicines, direct access to the lung is possible. Depending on the intrapulmonary behavior of each molecule, the aerosol mode of administration makes possible either a pulmonary topical action or a systemic action, thanks to the lung's wide vascular network. An inhaled molecule's pulmonary behavior is not predictable and must be studied on its own. Some medicines with a systemic aim have a topical effect after aerosol administration: furosemide, amiloride, morphine, interferons, cyclosporin and prostacyclin. Other medicines have systemic effects after aerosol administration: insulin, growth hormone, LHRH, calcitonin and nicotine. Heparin can be classified in either group depending on the dose and type of use.

  15. 76 FR 53816 - Advisory Committee; Change of Name and Function; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... Function; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The... the name and function of the Anesthetic and Life Support Drugs Advisory Committee. This action is... Support Drugs Advisory Committee name was changed and its functions expanded in the charter renewal dated...

  16. 75 FR 70932 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Anesthetic and Life Support Drugs... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Joint Meeting of the Anesthetic and Life...

  17. 76 FR 12972 - Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the... regarding their request to speak by April 26, 2011. FDA will work with sponsors of acetaminophen products...

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

    PubMed

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

    2017-02-01

    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.

  19. 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.

  20. 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

  1. United States Food and Drug Administration Product Label Changes

    PubMed Central

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

    2017-01-01

    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:28367259

  2. 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…

  3. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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 for disseminating drug information to participants and program staff. (a) Procedures. (1) The program...

  4. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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 for disseminating drug information to participants and program staff. (a) Procedures. (1) The program...

  5. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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 for disseminating drug information to participants and program staff. (a) Procedures. (1) The program...

  6. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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 for disseminating drug information to participants and program staff. (a) Procedures. (1) The program...

  7. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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 for disseminating drug information to participants and program staff. (a) Procedures. (1) The program...

  8. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... will receive a presentation on pediatric provisions mandated by the Food and Drug Administration Safety...

  9. 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

    ... HUMAN SERVICES Food and Drug Administration Seventh Annual Drug Information Association/Food and Drug... Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA... INFORMATION CONTACT: Constance Burnett, Drug Information Association, 800 Enterprise Rd., Horsham, PA 19044, 1...

  10. Drug administration through feeding tubes; an integrated qualification program.

    PubMed

    Martins Gonzaga do Nascimento, M; Max Moreira Reis, A; Yeznach Wick, J; Queiroz Ribeiro, A

    2012-01-01

    The literature documents numerous inconveniences of drug administration through feeding tubes. Actions to improve the quality of this practice are of great importance. The objective of this study is to describe the implementation process and results of an Integrated Program to improve drug administration through feeding tubes in a Brazilian general hospital. This is a descriptive study of a clinic quality improvement program which proceeded in four steps: (1) design of a data base with technical characteristics of oral drugs; (2) application of an identification label on non-crushable tablets; (3) evaluation, through focal groups, of nursing technicians' knowledge of drug administration through feeding tubes, and formal training; (4) prescription review of patients prescribed enteral nutrition and subsequent pharmaceutical intervention. A list with 131 oral drugs used within the hospital was compiled with recommendations for their administration through feeding tubes. Seven non-crushable drugs were identified with "do not crush" labels. Formal training regarding drug administration through feeding tubes was elaborated incorporating findings from the focal groups and applied to the nursing team. Over eight months, we analyzed 888 prescriptions written for 185 patients and addressed 263 pharmaceutical interventions to the medical team (which they accepted in 100% of the cases), and 105 interventions to the nursing team. Qualification programs with multiple strategies, as the one described here, may directly improve drug administration through feeding tubes and help to solve and prevent problems related to this practice.

  11. Evaluation of drug administration errors in a teaching hospital

    PubMed Central

    2012-01-01

    Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions. PMID:22409837

  12. Evaluation of drug administration errors in a teaching hospital.

    PubMed

    Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

    2012-03-12

    Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

  13. 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

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative... announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative... Transparency Initiative. This report includes eight initiatives adopted by the Commissioner of Food and Drugs...

  14. 75 FR 64736 - Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-20

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting nominations...

  15. 21 CFR 14.70 - Administrative record of a public hearing before an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... advisory committee. (a) Advice or recommendations of an advisory committee may be given only on matters... the committee. (4) All reports made by the committee. (5) Any reports prepared by a consultant under... advice or recommendations or at any earlier time specified by the committee or in other sections in this...

  16. Discovering the Regulatory Considerations of the Federal Aviation Administration: Interviewing the Aviation Rulemaking Advisory Committee

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsung

    2005-01-01

    Maintenance Resource Management (MRM) training for aviation mechanics has become mandatory in many industrialized countries since 1998. Yet, to date, MRM training remains optional in the U.S. Interestingly, a similar safety discipline, namely Crew/Cockpit Resource Management (CRM), is mandatory for pilots, flight engineers, flight attendants, and dispatchers and is regulated in the Federal Aviation Administration s (FAA) Federal Aviation Regulations (FARs). If MRM training is important to enhance aviation technicians working behavior, the rationale to not regulate it opens a window for study. This research aims to inductively investigate the FAA s regulatory rationale concerning MRM training based on direct inputs from the FAA s Aviation Rulemaking Advisory Committee (ARAC) members. Delphi methodology associated with purposive sampling technique was adopted. The result revealed that the FAA cannot regulate MRM because the aviation industry is strongly opposed to it due to the lack of training budgets, the need of a quantifiable cost-effect analysis, concern over the FAA s inspection workforce, an ongoing voluntary alternative called the Air Transportation Surveillance System (ATOS), the government s lower priority on maintenance after 9/11, and the airlines tight embracement of operational flexibility without regulation.

  17. 75 FR 30045 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... cancer known as HER2-negative breast cancer, in combination with the chemotherapy drug docetaxel; and (2) first-line treatment of HER2-negative metastatic breast cancer in combination with one of two classes of... for their locally recurrent or metastatic HER2 negative breast cancer. FDA intends to make...

  18. OxyContin: Prescription Drug Abuse. CSAT Advisory.

    ERIC Educational Resources Information Center

    Substance Abuse and Mental Health Services Administration (DHHS/PHS), Rockville, MD. Center for Substance Abuse Treatment.

    Recently, the media have issued numerous reports about the apparent increase in OxyContin abuse and addiction. OxyContin has been heralded as a miracle drug that allows patients with chronic pain to resume a normal life. It has also been called pharmaceutical heroin and is thought to have been responsible for a number of deaths and robberies in…

  19. Retention of drug administration skills after intensive teaching.

    PubMed

    Wheeler, D W; Degnan, B A; Murray, L J; Dunling, C P; Whittlestone, K D; Wood, D F; Smith, H L; Gupta, A K

    2008-04-01

    We have identified deficiencies in medical students' drug administration skills, and we attempted to address them with interactive online teaching modules and simulated critical incident scenarios. Short-term improvements have been evident with this intensive effort, but medium-term retention of skills has not been measured. A drug administration lecture, an online module and a simulated emergency scenario were offered to final year clinical students. None of the teaching was compulsory but participation was recorded, along with students' simulator performances and marks in an objective structured practical examination 9 months later. A poor simulator score predicted a poor performance in the later examination. Participation in the simulated scenario only significantly improved examination scores when supplemented by online teaching (p = 0.002). Intensive drug administration teaching using an online module and high fidelity simulation improves drug administration skills in the medium term. Students found simulation much more engaging than online teaching.

  20. Adverse drug reactions related to drug administration in hospitalized patients.

    PubMed

    Gallelli, Luca; Siniscalchi, Antonio; Palleria, Caterina; Mumoli, Laura; Staltari, Orietta; Squillace, Aida; Maida, Francesca; Russo, Emilio; Gratteri, Santo; De Sarro, Giovambattista

    2017-06-15

    Drug treatment may be related with the development of adverse drug reactions (ADRs). Here, we evaluated the ADRs in patients admitted to Catanzaro Hospital. After we obtained the approval by local Ethical Committee, we performed a retrospective study on clinical records from March 01, 2013 to April30, 2015. The association between drug and ADR or between drug and drug-drug-interactions (DDIs) was evaluated using the Naranjo's probability scale and Drug Interaction Probability Scale (DIPS), respectively. During this time, we analyzed 2870 clinical records and 11,138 prescriptions and we documented the development of 770 ADRs. The time of hospitalization was significantly higher (P<0.05) in women with ADRs (12.6± 1.2 days) respect to men (11.8± 0.83 days). Using the Naranjo score, we documented a probable association in 78% of these reactions, while DIPS revealed that about 22% of ADRs were related to DDIs. Patients with ADRs received 3052 prescription on 11,138 (27.4%), with a mean of 6.1±0.29 drugs that was significantly higher (P<0.01) respect to patients that not experienced ADRs (mean of 3.4±0.13 drugs). About 19% of ADRs were not diagnosed and treated as new disease. In conclusion, we documented that age and gender are risk factors for the development of ADRs, that in some patients are under-diagnosed. Therefore, it is important to motivate healthcare to report the ADRs in order optimize the patient safety. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  1. 75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-20

    ... HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee; Notice of Meeting... the public. Name of Committee: Risk Communication Advisory Committee. General Function of the... November 8 and 9, 2010, the Committee will hear and discuss developments in FDA's ongoing...

  2. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... meeting. Agenda: On July 22, 2013, the committee will discuss the Assessment of SpondyloArthritis...

  3. 75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  4. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency...

  5. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... HUMAN SERVICES Food and Drug Administration Veterinary Medicine Advisory Committee; Notice of Meeting... the public. Name of Committee: Veterinary Medicine Advisory Committee. General Function of the... Rockville Pike, Rockville MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for...

  6. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice...

  7. 77 FR 67013 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... to discuss labeling of Red Blood Cells with historical antigen typing results. On December 5, 2012... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee:...

  8. 75 FR 72834 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... 14, 2010, in the morning, the committee will discuss the risk of dengue virus infection in...

  9. 78 FR 2677 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee:...

  10. 78 FR 38351 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of..., Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends...

  11. 76 FR 14416 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To... use of plasma obtained from Whole Blood donors for further manufacturing. On April 29, 2011, in...

  12. 78 FR 56899 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors. In the...

  13. 75 FR 12768 - Blood Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of... Hematology, Office of Blood Research and Review, CBER, FDA. FDA intends to make background material...

  14. 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...

  15. 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...

  16. 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

    ... No. FDA-2010-N-0004] [FDA 225-09-0012] Memorandum of Understanding Between the Food and Drug...: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU...

  17. 76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration 2011 Parenteral Drug Association/Food and Drug... Parenteral Drug Association (PDA), is announcing a public conference entitled ``PDA/FDA Glass Quality... Association (PDA), PDA Global Headquarters, Bethesda Towers, 4350 East-West Highway, suite 200, Bethesda, MD...

  18. 21 CFR 20.107 - Food and Drug Administration manuals.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... affect a member of the public are available for public disclosure. An index of all such manuals is... Information Public Reading Room, located in rm. 1050, at the same address. The index and all manuals...

  19. FDA reform signed into law. Food and Drug Administration.

    PubMed

    James, J S

    1997-12-05

    The laws under which the Food and Drug Administration (FDA) operates have been changed by bipartisan Congressional efforts. The FDA Modernization Act of 1997, signed into law on November 21, 1997 modifies the mission of the FDA to include a goal of speeding research, innovation and access to care. The legislation allows fast track review for the most important drugs. It also allows drug companies to promote off label use of already-approved pharmaceuticals for other purposes. The controversial issue allows drug companies to provide physicians with documentation on the effectiveness of their drugs in treating other conditions. The industry supports the change since the revenue growth for off label use of drugs is especially important for smaller biotechnical companies, while consumer groups fear that it is a loophole for selling unproven drugs. The bill also renews the Prescription Drug User Fee Act (PDUFA), regulating the current practice of compounding, and monitoring medical devices and health care claims for foods.

  20. The formulation of drug for ocular administration.

    PubMed

    Aiache, J M; el Meski, S; Beyssac, E; Serpin, G

    1997-01-01

    The different barriers that slow the penetration of active ingredients administered by the ocular route are described, and some novel dosage forms designed for this route are discussed. Both precorneal and corneal factors considerably restrict ocular penetration. The low bioavailability of classical ophthalmic dosage forms can be improved by several approaches, particularly by increasing the time the active ingredients remain in contact with the eye tissues. The new dosage forms are reviewed according to their type and their drug release mechanisms. The characteristics, advantages, and limitations of each are outlined. The potential of these dosage forms can be expected to enhance development. They offer prolonged effectiveness, reproducibility, fewer unwanted side effects, and improved tolerance.

  1. 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

  2. 76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Postponement of... Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011...

  3. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological... announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on...

  4. 77 FR 55863 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... SPACE ADMINISTRATION NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of... Aeronautics and Space Administration (NASA) announces a meeting of the Applied Science Advisory Group. This...

  5. 76 FR 29752 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... Technology Management in the Federal Government, and Senior Executive Service (SES) Development and... ADMINISTRATION The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting.... SUMMARY: The President's Management Advisory Board, a Federal Advisory Committee established in...

  6. 67 FR 12587 - NASA Advisory Council, Space Science Advisory Committee, Structure and Evolution of the Universe...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2002-03-19

    ... SPACE ADMINISTRATION NASA Advisory Council, Space Science Advisory Committee, Structure and Evolution of... Advisory Council, Space Science Advisory Committee, Structure and Evolution of the Universe Subcommittee... Science Enterprise --Structure and Evolution of the Universe Overview: --Budget, Ongoing Programs, Future...

  7. 76 FR 32219 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... July 22, 2011, from 8 a.m. to 5 p.m. Location: Center for Tobacco Products, Food and Drug...

  8. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY...

  9. 78 FR 6824 - Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... HUMAN SERVICES Food and Drug Administration Considerations Regarding Food and Drug Administration Review... muscles. Messages from motor neurons in the brain (called ``upper motor neurons'') are transmitted to... (fasciculations). Eventually, the ability of the brain to start and control voluntary movement is lost. ALS...

  10. 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 for Nominations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... contact is Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire...

  11. 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

    ... 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, HHS. ACTION: Notice of public conference. The Food and Drug...

  12. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  13. 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... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section...

  14. 77 FR 26768 - Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/International Society for..., and Sustaining a Culture of Compliance AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Center for Drug Evaluation and Research, in...

  15. 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...

  16. Telematics integrated system to perform drugs prescription and administration reducing adverse drug events.

    PubMed

    Iadanza, E; Pettenati, M C; Bianchi, L; Turchi, S; Ciofi, L; Pirri, F; Biffi Gentili, G; Giuli, D

    2012-01-01

    In this paper we present PHARMA 2.0 a telematics integrated system aimed at reducing Adverse Drug Events (ADEs) in the phases of drug prescription, transcription, distribution and administration. The proposed system is grounded on three sub-systems: a CPOE (Computerized Prescription Order Entry), an RFID-based drug container and dispenser and a middleware system. The visualization and management of prescription and administration data are handled through a web application designed to comply with international usability regulation.

  17. Pressure ulcers induced by drug administration: A new concept and report of four cases in elderly patients.

    PubMed

    Mizokami, Fumihiro; Takahashi, Yoshiko; Hasegawa, Keiko; Hattori, Hideyuki; Nishihara, Keiji; Endo, Hidetoshi; Furuta, Katsunori; Isogai, Zenzo

    2016-04-01

    Drug-induced akinesia is a potential cause of pressure ulcers. However, pressure ulcers that are caused by drug-induced akinesia are not considered an adverse drug reaction (ADR). We propose that drug-induced pressure ulcers (DIPU) are pressure ulcers that are caused by an external force that is experienced after drug administration, and we considered resolution of these ulcers after drug discontinuation to be a supportive finding. In this report, we reviewed the medical records of pressure ulcer cases from a 300-bed hospital. Among 148 patients, four patients with pressure ulcers met the criterion for DIPU. In these cases, the suspected DIPU were related to treatment with olanzapine, fluvoxamine, valproic acid, clotiazepam, triazolam and rilmazafone. These drugs were administrated to manage the patients' behavioral and psychological symptoms that accompanied dementia. The DIPU in these patients were categorized as stage IV according to the National Pressure Ulcer Advisory Panel criteria. Discontinuation of the causal drugs led to significant improvements or complete healing of the pressure ulcers, and the patients subsequently recovered their mobility. Therefore, we propose that DIPU are potential ADR that have been overlooked in clinical practice. Thus, recognition of DIPU as an ADR may be important in preventing and appropriately managing pressure ulcers among elderly patients. © 2015 Japanese Dermatological Association.

  18. 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.

  19. [Behavioral correlations of gradual forced administration of psychoactive drugs].

    PubMed

    Shabanov, P D; Lebedev, A A

    2011-01-01

    The study was aimed at evaluating the behavioral correlations of the forced administration of psychoactive drugs. Wistar rats received the following drugs in elevated doses (over 4 days, i. p.): (i) physiological saline (control; 0.1-0.2-0.4-0.8 ml/rat), (ii) psychostimulant amphetamine (0.5-1.0--2.0-4.0 mg/kg); (iii) opioid analgetic fentanyl (0.00625-0.0125--0.025-0.05 mg/kg), (iv) ethanol 40% solution (0.5-1.0--2.0-4.0 g/kg), (v) barbiturate sodium ethaminal (2.5-5--10-20 mg/kg); and(vi) synthetic glucocorticoid dexamethasone (0.5-1.0--2.0-4.0 mg/kg). The forced regime of drug administration led to gradual load of the organism and prevented drug tolerance. The dynamics of self-stimulation reaction of the lateral hypothalamus was registered every day over drug administration period and revealed the following regularities: (I) dose-dependent effect of psychostimulant amphetamine and opioid analgetic fentanyl; (II) dexamethasone modulated self-stimulation, increasing (2 day, 1 mg/kg) or decreasing it (3 day, 2 mg/kg); (III) ethanol (1-2 g/kg) activated self-stimulation slightly; (IV) sodium ethaminal slightly inhibited self-stimulation and increased the thresholds of self-stimulation. In 24 h and 72 h after the last administration of drugs, the rat behavior was assessed in open field, elevated plus maze, resident-intruder paradigm, and Porsolt's test. In the open field, significant signs of post-intoxication exposure of psychoactive drugs were revealed, which were registered for 24-72 h after drug withdrawal. The withdrawal of drugs was accompanied with reduction (in 24 h) and subsequent recovery (in 72 h) of the vertical motor activity, exploration behavior, and emotionality. The anxiety indexes were increased up to the 3rd day after withdrawal. The antidepressant effect was also increased. The system of aggression-defense was restored only in rats treated with ethanol. The indexes of individual behavior and communicability in the post-intoxication period were

  20. Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon.

    PubMed

    Escárcega, Ricardo O; Waksman, Ron

    2014-01-01

    The Lutonix® drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2μg/mm(2) yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease. On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Lutonix DCB premarket approval application (PMA). This PMA application was primarily based on data from the pivotal randomized, controlled and multicenter clinical trial, which compared the Lutonix DCB with PTA. This summary aims to describe the discussions and recommendations made by the advisory panel during the meeting. Based on the Panel's recommendations, it is possible that the FDA will approve this device. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. 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.

  2. 75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... Syndrome, and recommend what regulatory actions, if any, are necessary to diminish the risks. FDA intends... http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll down to the appropriate advisory...

  3. 75 FR 32188 - Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ..., addiction, and death due to prescription opioid abuse and misuse have been increasing over the last decade... http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll down to the appropriate advisory... orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov...

  4. Improving Drugs Administration Safety in Pediatric Resuscitation Using Mobile Technology.

    PubMed

    Hagberg, Hamdi; Siebert, Johan; Gervaix, Alain; Daehne, Peter; Lovis, Christian; Manzano, Sergio; Ehrler, Frederic

    2016-01-01

    The fast preparation of drugs during pediatric resuscitation is of utmost importance. The influence of the patient's weight on the drug doses requires to perform complex calculations and is a source of errors. A technological solution could be a real help in avoiding these kinds of mistakes. Relying on a user centered approach we have developed an application supporting drug preparation. It has been tested in simulations with predefined scenario. The developed tool consists of a screen displaying a list of drug that can be administered. When the user select a drug, the instructions regarding its preparation are displayed with all dosage precisely calculated. The tool has demonstrated a significant reduction of errors associated to administration, a speeding up the overall process and has been well received by the nurses.

  5. 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…

  6. 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…

  7. 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.

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

    PubMed

    Hursh, S R

    1991-09-01

    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.

  9. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... products (products to suppress clotting of blood) in children. Issues for discussion will...

  10. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... ] (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... (Pub. L. 108-155) and the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and their...

  11. 75 FR 73984 - Amendments to General Regulations of the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend certain of its general...

  12. 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 University...

  13. 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; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA) is soliciting comments from interested persons on ways in...

  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 Medical Device 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...

  15. 75 FR 73951 - Amendments to General Regulations of the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug Administration (FDA) is amending certain of its general...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

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

  17. 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

    ... 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 public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a public...

  18. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

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

  19. 77 FR 40069 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... HUMAN SERVICES Food and Drug Administration Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency...

  20. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; 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 ``Highly...

  1. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... 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... Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical...

  2. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  3. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  4. 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, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Los Angeles...

  5. 78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    .../AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call... Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital disorder caused by the absence.../default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure: Interested...

  6. 21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Administration records. (a) The Food and Drug Administration will make the fullest possible disclosure of records... Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Administration records shall be made available for public disclosure. (c) Except as provided in paragraph (d)...

  7. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  8. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

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

  9. 78 FR 30305 - The President's Management Advisory Board (PMAB); Public Advisory Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... ADMINISTRATION The President's Management Advisory Board (PMAB); Public Advisory Meeting AGENCY: Office of Executive Councils, U.S. General Services Administration (GSA). ACTION: Notice. SUMMARY: The President's..., Designated Federal Officer, President's Management Advisory Board, Office of Executive Councils, General...

  10. 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...

  11. 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....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and...

  12. 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...

  13. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 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...

  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... this part is: Freedom of Information Staff (HFI-35), Food and Drug Administration, Room 12A-16, 5600...

  17. 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...

  18. 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... Procedures § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a) Regulations...

  19. 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)...

  20. 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)...

  1. 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... upon an officer or employee of the Food and Drug Administration commanding the production of any record...

  2. 21 CFR 20.2 - Production of records 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 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... upon an officer or employee of the Food and Drug Administration commanding the production of any record...

  3. 21 CFR 20.2 - Production of records 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 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... upon an officer or employee of the Food and Drug Administration commanding the production of any record...

  4. 21 CFR 20.2 - Production of records 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 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... upon an officer or employee of the Food and Drug Administration commanding the production of any record...

  5. 21 CFR 20.2 - Production of records 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 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... upon an officer or employee of the Food and Drug Administration commanding the production of any record...

  6. Orbitofrontal response to drug-related stimuli after heroin administration.

    PubMed

    Walter, Marc; Denier, Niklaus; Gerber, Hana; Schmid, Otto; Lanz, Christian; Brenneisen, Rudolf; Riecher-Rössler, Anita; Wiesbeck, Gerhard A; Scheffler, Klaus; Seifritz, Erich; McGuire, Philip; Fusar-Poli, Paolo; Borgwardt, Stefan

    2015-05-01

    The compulsion to seek and use heroin is frequently driven by stress and craving during drug-cue exposure. Although previous neuroimaging studies have indicated that craving is mediated by increased prefrontal cortex activity, it remains unknown how heroin administration modulates the prefrontal cortex response. This study examines the acute effects of heroin on brain function in heroin-maintained patients. Using a crossover, double-blind, placebo-controlled design, 27 heroin-maintained patients performed functional magnetic resonance imaging 20 minutes after the administration of heroin or placebo (saline) while drug-related and neutral stimuli were presented. Images were processed and analysed with statistical parametric mapping. Plasma concentrations of heroin and its main metabolites were assessed using high-performance liquid chromatography. Region of interest analyses showed a drug-related cue-associated blood-oxygen-level-dependent activation in the orbitofrontal cortex (OFC) in heroin-dependent patients during both treatment conditions (heroin and placebo). This activation of the OFC was significantly higher after heroin than after placebo administration. These findings may indicate the importance of OFC activity for impulse control and decision-making after regular heroin administration and may emphasize the benefit of the heroin-assisted treatment in heroin dependence.

  7. Potential of nanoparticulate drug delivery systems by intranasal administration.

    PubMed

    Ali, Javed; Ali, Mushir; Baboota, Sanjula; Sahani, Jasjeet Kaur; Ramassamy, Charles; Dao, Lé; Bhavna

    2010-05-01

    Due to number of problems related with oral, parenteral, rectal and other routes of drug administration, the interest of pharmaceutical scientists has increased towards exploring the possibilities of intranasal delivery of various drugs. Nasal drug delivery system is commonly known for the treatment of local ailments like cold, cough, rhinitis, etc. Efforts have been made to deliver various drugs, especially peptides and proteins, through nasal route for systemic use; utilizing the principles and concepts of various nanoparticulate drug delivery systems using various polymers and absorption promoters. The incorporation of drugs into nanoparticles might be a promising approach, since colloidal formulations have been shown to protect them from the degrading milieu in the nasal cavity and facilitate their transport across the mucosal barriers. The use of nanoparticles for vaccine delivery provides beneficial effect, by achieving good immune responses. This could be due to the fact that small particles can be transported preferentially by the lymphoid tissue of the nasal cavity (NALT). The brain gets benefited through the intranasal delivery as direct olfactory transport bypasses the blood brain barrier and nanoparticles are taken up and conveyed along cell processes of olfactory neurons through the cribriform plate to synaptic junctions with neurons of the olfactory bulb. The intranasal delivery is aimed at optimizing drug bioavailability for systemic drugs, as absorption decreases with increasing molecular weight, and for drugs, which are susceptible to enzymatic degradation such as proteins and polypeptides. This review discusses the potential benefits of using nanoparticles for nasal delivery of drugs and vaccines for brain, systemic and topical delivery. The article aims at giving an insight into nasal cavity, consideration of factors affecting and strategies to improve drug absorption through nasal route, pharmaceutical dosage forms and delivery systems with

  8. 21 CFR 14.30 - Chairperson of an advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Chairperson of an advisory committee. 14.30 Section 14.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL..., or to take any other action to further a fair and expeditious hearing or meeting. (b) If...

  9. 21 CFR 14.30 - Chairman of an advisory committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Chairman of an advisory committee. 14.30 Section 14.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... take any other action to further a fair and expeditious hearing or meeting. (b) If the chairman is...

  10. 21 CFR 14.30 - Chairperson of an advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Chairperson of an advisory committee. 14.30 Section 14.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL..., or to take any other action to further a fair and expeditious hearing or meeting. (b) If...

  11. 21 CFR 14.30 - Chairman of an advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chairman of an advisory committee. 14.30 Section 14.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... take any other action to further a fair and expeditious hearing or meeting. (b) If the chairman is...

  12. 21 CFR 14.95 - Compensation of advisory committee members.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... Product Radiation Safety Standards Committee (TEPRSSC) are not appointed as special Government...

  13. 21 CFR 14.55 - Termination of advisory committees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Termination of advisory committees. 14.55 Section 14.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) of the Public Health Service Act, as added by the Radiation Control for Health and Safety Act of...

  14. Toxicology at the Food and Drug Administration: new century, new challenges.

    PubMed

    Schwetz, B A

    2001-01-01

    Dr. Schwetz is the Acting Deputy Commissioner of the Food and Drug Administration (FDA). He was Director of FDA National Center for Toxicological Research in Jefferson, AR, from 1993 to 1999. A diplomate of the American Board of Toxicology, Dr. Schwetz was acting Director of the Environmental Toxicology Program at the National Institutes of Health National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, NC, before coming to the FDA in 1993. He was also Associate Director of the National Toxicology program there. He had been Chief of the Institute Systems Toxicity Branch since 1982. Dr. Schwetz currently serves as Adjunct Professor, Department of Pharmacology and Toxicology/Division of Interdisciplinary Toxicology, at the University of Arkansas for Medical Sciences. He was editor of Fundamental and Applied Toxicology from 1986 to 1992, and serves on the Editorial Advisory Board of Environmental Health Perspectives and Critical Reviews in Toxicology. Dr. Schwetz is an invited member of the Canada Health Protection Branch Science Advisory Board, and an elected member of the National Academy of Sciences Institute of Medicine. He is a member of the Society of Toxicology (SOT) and the National Capitol Area Chapter, SOT; the American Veterinary Medical Association; National Society of Phi Zeta, Honor Society of Veterinary Medicine; Teratology Society; Behavioral Teratology Society; and the Reproductive Toxicology Specialty Section of the SOT. He is past president of the Reproductive Toxicology Specialty Section of the SOT and of the North Carolina and the South Central Chapters of the SOT. In addition to numerous other professional awards during his career, Dr. Schwetz received the U.S. Government 1998 Meritorious Executive Presidential Rank Award.

  15. 76 FR 72954 - Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research... HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration...

  16. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory... should have normal gonioscopic anatomy and a visually significant cataract eligible...

  17. Intravenous drug administration: a skill for student nurses?

    PubMed

    Morris, Ruth

    2006-04-01

    This article explores issues related to children's nursing students learning about preparation and administration of IV drugs, considering professional and organisational issues. The competencies required for safe practice are discussed, and the question of who is in the best position to teach and assess students in this skill is considered. Organisations need to ensure that clear guidelines exist for student nurses' involvement in IV therapy.

  18. 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.

  19. 75 FR 4982 - Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ... Enforcement Administration Official AGENCY: Drug Enforcement Administration (DEA), Department of Justice... Administration (DEA), Department of Justice, is amending the appendix to the Justice Department regulations to... Substances Act and subsequently delegated to the Administrator of DEA. DATES: Effective Dates: This...

  20. Adverse Drug Events caused by Serious Medication Administration Errors

    PubMed Central

    Sawarkar, Abhivyakti; Keohane, Carol A.; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

    2013-01-01

    OBJECTIVE To determine how often serious or life-threatening medication administration errors with the potential to cause patient harm (or potential adverse drug events) result in actual patient harm (or adverse drug events (ADEs)) in the hospital setting. DESIGN Retrospective chart review of clinical events that transpired following observed medication administration errors. BACKGROUND Medication errors are common at the medication administration stage for hospitalized patients. While many of these errors are considered capable of causing patient harm, it is not clear how often patients are actually harmed by these errors. METHODS In a previous study where 14,041 medication administrations in an acute-care hospital were directly observed, investigators discovered 1271 medication administration errors, of which 133 had the potential to cause serious or life-threatening harm to patients and were considered serious or life-threatening potential ADEs. In the current study, clinical reviewers conducted detailed chart reviews of cases where a serious or life-threatening potential ADE occurred to determine if an actual ADE developed following the potential ADE. Reviewers further assessed the severity of the ADE and attribution to the administration error. RESULTS Ten (7.5% [95% C.I. 6.98, 8.01]) actual adverse drug events or ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% [95% C.I. 2.12, 3.6]) serious and life threatening potential ADEs led to serious or life threatening ADEs. Half of the ten actual ADEs were caused by dosage or monitoring errors for anti-hypertensives. The life threatening ADE was caused by an error that was both a transcription and a timing error. CONCLUSION Potential ADEs at the medication administration stage can cause serious patient harm. Given previous estimates of serious or life-threatening potential ADE of 1.33 per 100

  1. 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. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. 76 FR 58019 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory... p.m., and on November 3, 2011, from 8 a.m. to 5 p.m. Location: Center for Tobacco Products, Food...

  3. 76 FR 4705 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-26

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory.... Location: Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD, 20850. The telephone number...

  4. 77 FR 7589 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory.... to 5 p.m., and on March 2, 2012, from 8 a.m. to 1 p.m. Location: Center for Tobacco Products,...

  5. 76 FR 72422 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... [Docket No. FDA-2011-N-0002] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY... will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory Committee... Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1 (877)...

  6. 76 FR 2398 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory.... Location: Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD 20850. The phone number is...

  7. 75 FR 65641 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of... Meetings.'' Contact Person: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and...

  8. 75 FR 47308 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Products Scientific Advisory Committee General Function of... number is 301-590-0044. Contact Person: Cristi Stark, Center for Tobacco Products, Food and...

  9. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... HUMAN SERVICES Food and Drug Administration Molecular and Clinical Genetics Panel of the Medical Devices... Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published... meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, and the...

  10. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  11. 75 FR 72832 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  12. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  13. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  14. 77 FR 73472 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and...

  15. 77 FR 63840 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee..., Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and..., Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and the...

  16. 78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to...

  17. 76 FR 22405 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... gene therapy products for the treatment of retinal disorders. Topics to be considered include the...

  18. 76 FR 81513 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee..., Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and... Gene Therapies, Center for Biologics Evaluation and Research, FDA. FDA intends to make background...

  19. 75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... Lentiviral Vector Based Gene Therapy Products. FDA intends to make background material available to the...

  20. 78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee... on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for...

  1. 75 FR 65640 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and... Tumor Vaccines and Biotechnology Branch, Office of Cellular, Tissue and Gene Therapies, Center for...

  2. 76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee... be open to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee...

  3. 76 FR 18768 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to...

  4. 75 FR 36432 - Tobacco Products Scientific Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Amendment of...) is announcing an amendment to the notice of meeting of the Tobacco Products Scientific Advisory... portion is changed to cancel Topic 1 regarding dissolvable tobacco products. This portion of the meeting...

  5. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends to...

  6. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-08

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated...

  7. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season. FDA...

  8. 77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15...

  9. Oral Administration of Peptide-Based Drugs: Beyond Lipinski's Rule.

    PubMed

    Santos, Gabriela B; Ganesan, A; Emery, Flavio S

    2016-10-19

    The use of peptides in therapy presents several limitations, from physicochemical characteristics to inadequate pharmacokinetic profiles for oral absorption. As peptides are gaining importance in the therapeutic arsenal, there is an increasing need to rationalize the main characteristics of this compound class in the market. Therefore, we performed an extensive analysis of all known peptide drugs and clinical candidates based on their peptide features, physicochemical and structural properties, and correlated these with their administration route and therapeutic classes. Peptide drugs are widely distributed across drug and pharmacological space, covering several therapeutic areas with structural diversity and complexity, distributed between groups of cyclic and linear compounds. Although structural and physicochemical properties are clear within these groups, we counter the consensus that cyclic peptides have better oral availability than linear peptides, as most of the orally administrated peptides have linear structures. This study and review furnishes information that could support peptide drug design, with a new cutoff of known descriptors that go beyond the Rule of Five.

  10. The TREAT-NMD advisory committee for therapeutics (TACT): an innovative de-risking model to foster orphan drug development.

    PubMed

    Heslop, Emma; Csimma, Cristina; Straub, Volker; McCall, John; Nagaraju, Kanneboyina; Wagner, Kathryn R; Caizergues, Didier; Korinthenberg, Rudolf; Flanigan, Kevin M; Kaufmann, Petra; McNeil, Elizabeth; Mendell, Jerry; Hesterlee, Sharon; Wells, Dominic J; Bushby, Kate

    2015-04-23

    Despite multiple publications on potential therapies for neuromuscular diseases (NMD) in cell and animal models only a handful reach clinical trials. The ability to prioritise drug development according to objective criteria is particularly critical in rare diseases with large unmet needs and a limited numbers of patients who can be enrolled into clinical trials. TREAT-NMD Advisory Committee for Therapeutics (TACT) was established to provide independent and objective guidance on the preclinical and development pathway of potential therapies (whether novel or repurposed) for NMD.We present our experience in the establishment and operation of the TACT. TACT provides a unique resource of recognized experts from multiple disciplines. The goal of each TACT review is to help the sponsor to position the candidate compound along a realistic and well-informed plan to clinical trials, and eventual registration. The reviews and subsequent recommendations are focused on generating meaningful and rigorous data that can enable clear go/no-go decisions and facilitate longer term funding or partnering opportunities. The review process thereby acts to comment on viability, de-risking the process of proceeding on a development programme.To date TACT has held 10 review meeting and reviewed 29 program applications in several rare neuromuscular diseases: Of the 29 programs reviewed, 19 were from industry and 10 were from academia; 15 were for novel compounds and 14 were for repurposed drugs; 16 were small molecules and 13 were biologics; 14 were preclinical stage applications and 15 were clinical stage applications. 3 had received Orphan drug designation from European Medicines Agency and 3 from Food and Drug Administration. A number of recurrent themes emerged over the course of the reviews and we found that applicants frequently require advice and education on issues concerned with preclinical standard operating procedures, interactions with regulatory agencies, formulation

  11. 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...

  12. 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...

  13. 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...

  14. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  15. 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

    ... HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug... Health AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and...

  16. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... about the potential adverse health effects from the use of powder on medical gloves and is...

  17. Unapproved drugs in the United States and the Food and Drug Administration.

    PubMed

    Nasr, Alexander; Lauterio, Thomas J; Davis, Matthew W

    2011-10-01

    Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. Intervening legislation, such as the Federal Food, Drug, and Cosmetic Act of 1938 and Kefauver-Harris Amendments in 1962, was later instituted. In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs-Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.

  18. How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?

    PubMed

    McKee, Amy E; Markon, André O; Chan-Tack, Kirk M; Lurie, Peter

    2017-10-01

    In this review of individual patient expanded-access requests to the Center for Drug Evaluation and Research for the period Fiscal Year 2010 to Fiscal Year 2014, we evaluated the number of applications received and the number allowed to proceed. We also evaluated whether drugs and certain biologics obtained under expanded access went on to be approved by the Food and Drug Administration. Finally, we considered concerns that adverse events occurring during expanded access might place sponsors at risk for legal liability. Overall, 98% of individual patient expanded-access requests were allowed to proceed. During the study period, among drugs without a previous approval for any indication or dosage form, 24% of unique drugs (ie, multiple applications for access to the same drug were considered to relate to 1 unique drug), and 20% of expanded-access applications received marketing approval by 1 year after initial submission; 43% and 33%, respectively, were approved by 5 years after initial submission. A search of 3 legal databases and a database of news articles did not appear to identify any product liability cases arising from the use of a product in expanded access. Our analyses seek to give physicians and patients a realistic perspective on the likelihood of a drug's approval as well as certain information regarding the product liability risks for commercial sponsors when providing expanded access to investigational drugs. The US Food and Drug Administration (FDA)'s expanded-access program maintains a careful balance between authorizing patient access to potentially beneficial drugs and protecting them from drugs that may have unknown risks. At the same time, the agency wishes to maintain the integrity of the clinical trials process, ultimately the best way to get safe and effective drugs to patients. © 2017, The American College of Clinical Pharmacology.

  19. Sequential drug verification errors resulting in wrong drug administration during caesarean section.

    PubMed

    Calderbank, S; Uncles, D R; Burns, N; Kariyawasam, H K C D; Allan, G D L

    2011-01-01

    An intravenous bolus of phentolamine was inadvertently given to a parturient during an emergency caesarean section following delivery of her infant when the intention had been to give an intravenous bolus of 5 IU Syntocinon. Root cause analysis identified a series of errors originating in the hospital pharmacy when one drug package was mistakenly issued in place of another. Subsequent checks failed to detect the original mistake. The final and most important check immediately before intravenous administration was also at fault. This case highlights a systems failure that permitted issue, transportation and administration of the wrong drug to a parturient. Robust measures to ensure avoidance of drug administration errors should be evaluated and introduced where possible.

  20. 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 Drug...

  1. Opioid analgesic administration in patients with suspected drug use.

    PubMed

    Kreling, Maria Clara Giorio Dutra; Mattos-Pimenta, Cibele Andrucioli de

    2017-01-01

    To identify the prevalence of patients suspected of drug use according to the nursing professionals' judgement, and compare the behavior of these professionals in opioid administration when there is or there is no suspicion that patient is a drug user. A cross-sectional study with 507 patients and 199 nursing professionals responsible for administering drugs to these patients. The Chi-Square test, Fisher's Exact and a significance level of 5% were used for the analyzes. The prevalence of suspected patients was 6.7%. The prevalence ratio of administration of opioid analgesics 'if necessary' is twice higher among patients suspected of drug use compared to patients not suspected of drug use (p = 0.037). The prevalence of patients suspected of drug use was similar to that of studies performed in emergency departments. Patients suspected of drug use receive more opioids than patients not suspected of drug use. Identificar a prevalência de pacientes com suspeita de uso de drogas conforme opinião de profissionais de enfermagem e comparar a conduta desses profissionais na administração de opioides quando há ou não suspeita de que o paciente seja usuário de drogas. Estudo transversal com 507 pacientes e 199 profissionais de enfermagem responsáveis pela administração de medicamentos a esses pacientes. Para as análises foram utilizados os testes de Qui-Quadrado, Exato de Fisher e um nível de significância de 5%. A prevalência de pacientes suspeitos foi 6,7%. A razão de prevalência de administração de analgésicos opioides "se necessário" é duas vezes maior entre os pacientes suspeitos em relação aos não suspeitos (p=0,037). A prevalência de suspeitos foi semelhante à de estudos realizados em departamentos de emergência. Os suspeitos de serem usuários de drogas recebem mais opioides do que os não suspeitos.

  2. 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.

  3. [Intravesical therapy with mitomycin through electromotive drug administration].

    PubMed

    Verri, Cristian; Liberati, Emanuele; Celestino, Francesco; De Carlo, Francesco; Torelli, Fiammetta; Di Stasi, Savino M

    2013-01-01

    In the management of non-muscle invasive bladder cancer (NMIBC), high-level evidence supports the widespread practice of intravesical therapy with mitomycin-C (MMC). Randomized trials showed a significant reduction in short-term recurrence compared with transurethral resection of bladder tumor (TURBT) alone, but little effect on long-term and no impact at all in preventing progression. Electromotive drug administration (EMDA®) offers a means of controlling and enhancing the tissue transport of certain drugs, in order to increase their efficacy. In both laboratory and clinical studies, intravesical electromotive drug administration (EMDA) increases MMC bladder uptake, resulting in an improved clinical efficacy in NMIBC without systemic side effects. New frameworks for treatment of NMIBC - e.g., sequential intravesical BCG and EMDA/MMC, as well as intravesical EMDA/MMC immediately before TURBT - have provided promising preliminary results with higher remission rates and longer remission times, and they are a priority to minimise the costs of disease management. These findings suggest EMDA-enhanced MMC efficacy against urothelial cancer could be a major therapeutic breakthrough in the treatment of NMIBC.

  4. 75 FR 15342 - Advisory Committees; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... committees to reflect an internal change with respect to the staff that handles the nomination and selection...: Dornette D. Spell LeSane, Advisory Committee Oversight and Management Staff, Food and Drug Administration... Committee Oversight and Management Staff (ACOMS), within FDA's Office of the Commissioner, now...

  5. [Internet and nursing: development of a site on drug administration].

    PubMed

    da Silva, F B; Cassiani, S H; Zem-Mascarenhas, S H

    2001-01-01

    This study identified existent sites in the internet about Administration of Medications and developed and evaluated a specific site of this thematic. Of the 158 existent and available sites in the database of the Alta Vista search, 17 of these presented some relationship with pharmacology, marketing and information about drugs, technologies and rules of the medication. After that a site was developed and named The process of Administration of Medications in focus which goal was to present investigations conducted by a group about the following topics: errors, technology, complications, study group and the team. The evaluation of this site was made by 2 analyst of systems, 2 computer science technicians and 4 nursing professors and it showed that the quality of the pages, the time of answer, the link, images and content were considered between excellent and satisfactory.

  6. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... coronary syndrome [ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable... material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll down to the...

  7. 78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS- d). The.../Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure...

  8. 77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-25

    ... the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the... failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. During the afternoon.../default.htm . Scroll down to the appropriate advisory committee link. Procedure: Interested persons may...

  9. 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

  10. Hospice nurses' views on single nurse administration of controlled drugs.

    PubMed

    Taylor, Vanessa; Middleton-Green, Laura; Carding, Sally; Perkins, Paul

    2015-07-01

    The involvement of two nurses to dispense and administer controlled drugs is routine practice in most clinical areas despite there being no legal or evidence-based rationale. Indeed, evidence suggests this practice enhances neither safety nor care. Registered nurses at two hospices agreed to change practice to single nurse dispensing and administration of controlled drugs (SNAD). Participants' views on SNAD were evaluated before and after implementation. The aim of this study was to explore the views and experiences of nurses who had implemented SNAD and to identify the views and concerns of those who had not yet experienced SNAD. Data was obtained through semi-structured interviews. Qualitative thematic analysis of interview transcripts identified three key themes: practice to enhance patient benefit and care; practice to enhance nursing care and satisfaction; and practice to enhance organisational safety. The findings have implications for the understanding of influences on medicines safety in clinical practice and for hospice policy makers.

  11. 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

  12. How the US Food and Drug Administration can solve the prescription drug shortage problem.

    PubMed

    Schweitzer, Stuart O

    2013-05-01

    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.

  13. Drug Administration Errors in Hospital Inpatients: A Systematic Review

    PubMed Central

    Berdot, Sarah; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre; Sabatier, Brigitte

    2013-01-01

    Context Drug administration in the hospital setting is the last barrier before a possible error reaches the patient. Objectives We aimed to analyze the prevalence and nature of administration error rate detected by the observation method. Data Sources Embase, MEDLINE, Cochrane Library from 1966 to December 2011 and reference lists of included studies. Study Selection Observational studies, cross-sectional studies, before-and-after studies, and randomized controlled trials that measured the rate of administration errors in inpatients were included. Data Extraction Two reviewers (senior pharmacists) independently identified studies for inclusion. One reviewer extracted the data; the second reviewer checked the data. The main outcome was the error rate calculated as being the number of errors without wrong time errors divided by the Total Opportunity for Errors (TOE, sum of the total number of doses ordered plus the unordered doses given), and multiplied by 100. For studies that reported it, clinical impact was reclassified into four categories from fatal to minor or no impact. Due to a large heterogeneity, results were expressed as median values (interquartile range, IQR), according to their study design. Results Among 2088 studies, a total of 52 reported TOE. Most of the studies were cross-sectional studies (N=46). The median error rate without wrong time errors for the cross-sectional studies using TOE was 10.5% [IQR: 7.3%-21.7%]. No fatal error was observed and most errors were classified as minor in the 18 studies in which clinical impact was analyzed. We did not find any evidence of publication bias. Conclusions Administration errors are frequent among inpatients. The median error rate without wrong time errors for the cross-sectional studies using TOE was about 10%. A standardization of administration error rate using the same denominator (TOE), numerator and types of errors is essential for further publications. PMID:23818992

  14. Food and drug administration regulation of drugs that raise blood pressure.

    PubMed

    Blankfield, Robert P; Iftikhar, Imran H

    2015-01-01

    Although it is recognized that a systolic blood pressure (SBP) increase ≥ 2 mm Hg or a diastolic blood pressure (DBP) increase ≥ 1 mm Hg increases the risk of heart attacks and strokes in middle-aged adults, the Food and Drug Administration (FDA) lacks an adequate policy for regulating medications that increase blood pressure (BP). Some FDA reviewers consider a clinically significant increase in BP to occur only if a drug raises SBP ≥ 20 mm Hg or if a drug raises DBP ≥ 10 to 15 mm Hg. In recent years, numerous drugs have been regulated or taken off the market due to cardiovascular safety concerns. The list includes rofecoxib (Vioxx), valdecoxib (Bextra), nonselective nonsteroidal anti-inflammatory drugs, sibutramine (Meridia), and phenylpropanolamine. It is probable that the hypertensive effect of these drugs explains why they increase the risk of adverse cardiovascular events. Other drugs, notably serotonin-norepinephrine reuptake inhibitors and drugs used to treat attention deficit hyperactivity disorder, were approved without cardiovascular safety data despite the fact that they raise BP comparable to valdecoxib and sibutramine. It is the responsibility of the FDA to ensure that drugs are properly labeled regarding risk. Even if a drug raises BP only modestly, FDA guidelines for new drug approvals should include a requirement for cardiovascular safety data. However, such guidelines will not address the problem of how to obtain cardiovascular safety data for the many already approved drugs that increase BP. The FDA should play a role in obtaining cardiovascular safety data for such drugs.

  15. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period...

  16. 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

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  17. 78 FR 76842 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel Endpoints for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION:...

  18. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  19. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... 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...

  20. 21 CFR 20.110 - Data and information about Food and Drug Administration employees.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.110 Data and information about Food and Drug Administration employees. (a) The name, title, grade, position...

  1. 21 CFR 20.110 - Data and information about Food and Drug Administration employees.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.110 Data and information about Food and Drug Administration employees. (a) The name, title, grade, position...

  2. 78 FR 49988 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 Food and Drug Administration Food... of Third-Party Auditors/Certification Bodies; Public Meeting AGENCY: Food and Drug Administration... proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies would strengthen the...

  3. 78 FR 57320 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... importers currently rely to help manage the safety of their global food supply chains. The purpose of these... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 Food and Drug Administration Food... of Third-Party Auditors/Certification Bodies; Public Meetings AGENCY: Food and Drug Administration...

  4. 77 FR 16923 - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 20 Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations AGENCY: Food...-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers...

  5. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ...] [FR Doc No: 2010-20834] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION...

  6. 75 FR 4631 - Open Season for Membership to the Electronic Tax Administration Advisory Committee (ETAAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... implementation of the Internal Revenue Service (IRS) strategy for electronic tax administration. The ETAAC... options and best practices), (8) system integrators (technology providers), (9) academic (marketing,...

  7. 77 FR 56909 - Aviation Rulemaking Advisory Committee (ARAC); Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... Federal Aviation Administration Aviation Rulemaking Advisory Committee (ARAC); Renewal AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Renewal. SUMMARY: The FAA announces the charter renewal of the Aviation Rulemaking Advisory Committee (ARAC), a Federal Advisory Committee that works...

  8. 75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces that the Agency's Motor Carrier Safety Advisory Committee...

  9. 75 FR 50797 - Motor Carrier Safety Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces that its Motor Carrier Safety Advisory Committee (MCSAC)...

  10. 75 FR 29384 - Motor Carrier Safety Advisory Committee Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... Federal Motor Carrier Safety Administration Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee meeting. SUMMARY: FMCSA announces that its Motor Carrier Safety Advisory Committee (MCSAC)...

  11. 78 FR 53497 - Commercial Space Transportation Advisory Committee; Closed Session

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... Federal Aviation Administration Commercial Space Transportation Advisory Committee; Closed Session AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory... closed session of the Commercial Space Transportation Advisory Committee (COMSTAC). The special...

  12. 75 FR 57102 - Occupational Information Development Advisory Panel Meeting; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

    ... ADMINISTRATION Occupational Information Development Advisory Panel Meeting; Correction AGENCY: Social Security... Occupational Information Development Advisory Panel. The document contained an incorrect timeframe for the...: Occupational Information Development Advisory Panel, Social Security Administration, 6401 Security Boulevard...

  13. 76 FR 40768 - Occupational Information Development Advisory Panel Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... ADMINISTRATION Occupational Information Development Advisory Panel Meeting AGENCY: Social Security Administration... Development Advisory Panel (panel) is a discretionary panel, established under the Federal Advisory Committee... development and testing of a content model and taxonomy, work analysis instrumentation, sampling, and data...

  14. 76 FR 70804 - Occupational Information Development Advisory Panel Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-15

    ... ADMINISTRATION Occupational Information Development Advisory Panel Meeting AGENCY: Social Security Administration... Development Advisory Panel (panel) is a discretionary panel, established under the Federal Advisory Committee... development and testing of a content model and taxonomy, work analysis instrumentation, sampling, and data...

  15. 77 FR 70482 - Notice of Establishment of a NASA Federal Advisory Committee; Applied Sciences Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SPACE ADMINISTRATION Notice of Establishment of a NASA Federal Advisory Committee; Applied Sciences... the establishment of the Applied Sciences Advisory Committee as a Federal advisory committee under... Integration and Management Division, Science Mission Directorate, NASA Headquarters, 300 E Street...

  16. 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

  17. 28 CFR 0.103a - Delegations respecting claims against the Drug Enforcement Administration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Delegations respecting claims against the Drug Enforcement Administration. 0.103a Section 0.103a Judicial Administration DEPARTMENT OF JUSTICE ORGANIZATION OF THE DEPARTMENT OF JUSTICE Drug Enforcement Administration § 0.103a Delegations...

  18. 61 FR 46667 - NASA Advisory Council (NAC), Space Science Advisory Committee (SScAC), Structure and Evolution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    1996-09-04

    ... From the Federal Register Online via the Government Publishing Office NATIONAL AERONAUTICS AND SPACE ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION NASA Advisory Council (NAC), Space Science Advisory Committee (SScAC), Structure and Evolution of the Universe Advisory Subcommittee; Meeting...

  19. Human schistosomiasis in the post mass drug administration era.

    PubMed

    Mutapi, Francisca; Maizels, Rick; Fenwick, Alan; Woolhouse, Mark

    2017-02-01

    Profound changes are occurring in the epidemiology of schistosomiasis, a neglected tropical disease caused by a chronic infection with parasitic helminths of the genus Schistosoma. Schistosomiasis currently affects 240 million people worldwide, mostly in sub-Saharan Africa. The advent and proliferation of mass drug administration (MDA) programmes using the drug praziquantel is resulting in substantial increases in the number of people, mainly children aged 6-14 years, being effectively treated, approaching the point where most people in endemic areas will receive one or more treatments during their lifetimes. Praziquantel treatment not only cures infection but also frees the host from the powerful immunomodulatory action of the parasites. The treatment simultaneously enhances exposure to key parasite antigens, accelerating the development of protective acquired immunity, which would take many years to develop naturally. At a population level, these changes constitute a substantial alteration to schistosome ecology in that the parasites are more likely to be exposed not only to praziquantel directly but also to hosts with altered immune phenotypes. Here, we consider the consequences of this for schistosome biology, immunoepidemiology, and public health. We anticipate that there could be substantial effects on chronic pathology, natural immunity, vaccine development strategies, immune disorders, and drug efficacy. This makes for a complex picture that will only become apparent over decades. We recommend careful monitoring and assessment to accompany the roll-out of MDA programmes to ensure that the considerable health benefits to populations are achieved and sustained. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. 77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Single-Ingredient, Immediate-Release Drug Products... AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug... such products in interstate commerce. The document was published with an incorrect Web link....

  1. 49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

  2. 49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

  3. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 drug... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration...

  4. 21 CFR 874.5220 - Ear, nose, and throat drug administration device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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 drug... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration...

  5. 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 OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.29 Prohibition on...

  6. 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 Food...

  7. Reform at FDA: faster access to promising drugs? Food and Drug Administration.

    PubMed

    Baker, R

    1995-06-01

    The Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs, vaccines, and medical devices are safe and effective, is under hot debate by Congress, the Clinton administration, and the AIDS community. The Clinton/Gore proposal favors excluding drug and biologic manufacturers from requirements for more environmental assessments and only indirectly addresses drug development. Oregon Democratic Congressman Ron Wyden introduced an FDA reform bill which calls for the FDA to use expert panels, independent testing organizations, and institutional review boards (IRB) to help speed new drugs and devices through the approval process. The bill calls for the use of the IRB for the approval (or denial) of applications for Phase I review of new drugs. Not surprisingly, the AIDS community has differing views on the reform at the FDA. The Treatment Action Group (TAG), whose members hold key positions in well-known AIDS groups, supports the status quo at FDA and is lobbying AIDS organizations across the country to sign on to its FDA Reform Principles. Other AIDS treatment activists, such as members of ACT UP, favor local IRB jurisdiction over Phase I research.

  8. Annual report of the National Advisory Committee for Aeronautics (40th). administrative report including Technical Report nos. 1158-1209

    NASA Technical Reports Server (NTRS)

    1956-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  9. Annual report of the National Advisory Committee for Aeronautics (44th). administrative report including Technical Report nos. 1342 to 1366

    NASA Technical Reports Server (NTRS)

    1959-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  10. Annual report of the National Advisory Committee for Aeronautics (34th). administrative report including Technical Report nos. 892 to 921

    NASA Technical Reports Server (NTRS)

    1951-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  11. Annual report of the National Advisory Committee for Aeronautics (37th). administrative report including Technical Report nos. 1003 to 1031

    NASA Technical Reports Server (NTRS)

    1952-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  12. Annual report of the National Advisory Committee for Aeronautics (42nd). administrative report including Technical Report nos. 1254 to 1295

    NASA Technical Reports Server (NTRS)

    1957-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  13. Annual report of the National Advisory Committee for Aeronautics (35th). administrative report including Technical Report nos. 922 to 950

    NASA Technical Reports Server (NTRS)

    1951-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  14. Annual report of the National Advisory Committee for Aeronautics (38th). administrative report including Technical Report nos. 1059 to 1110

    NASA Technical Reports Server (NTRS)

    1954-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  15. Annual report of the National Advisory Committee for Aeronautics (36th). administrative report including Technical Report nos. 951 to 1002

    NASA Technical Reports Server (NTRS)

    1951-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  16. Annual report of the National Advisory Committee for Aeronautics (41st). administrative report including Technical Report nos. 1210 to 1253

    NASA Technical Reports Server (NTRS)

    1957-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  17. Annual report of the National Advisory Committee for Aeronautics (29th) : administrative report including Technical Report nos. 752 to 773

    NASA Technical Reports Server (NTRS)

    1948-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, summaries of the committee's activities and research accomplished, bibliographies, and financial report.

  18. 78 FR 51191 - Government-wide Travel Advisory Committee (GTAC); Public Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... ADMINISTRATION Government-wide Travel Advisory Committee (GTAC); Public Advisory Committee Meeting AGENCY: Office... Government-wide Travel Advisory Committee (GTAC) (the Committee), is a Federal Advisory Committee established in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C., App 2. This ] notice...

  19. 78 FR 56231 - Government-Wide Travel Advisory Committee (GTAC); Public Advisory Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... ADMINISTRATION Government-Wide Travel Advisory Committee (GTAC); Public Advisory Committee Meeting AGENCY: Office... Government-wide Travel Advisory Committee (GTAC) (the Committee), is a Federal Advisory Committee established... CONTACT: Ms. Marcerto Barr, Designated Federal Officer (DFO), Government-wide Travel Advisory Committee...

  20. Characteristics of small residential and commercial water systems that influence their likelihood of being on drinking water advisories in rural British Columbia, Canada: a cross-sectional study using administrative data.

    PubMed

    Edwards, Joanne E; Henderson, Sarah B; Struck, Sylvia; Kosatsky, Tom

    2012-12-01

    Health officials often lack information about characteristics that predict which water systems are most likely to be placed on and to persist on drinking water advisories (e.g. health warnings offering advice or information). This study uses data collected by the Interior Health Authority in British Columbia to characterize water systems on advisory for microbiological threats and to identify the variables associated with advisory status and length. By systematically extracting key characteristics, this study explores advisory status by examining associated variables: water systems size, administrative area, governance structure, water source, treatment level, and service type (e.g. residential or commercial systems). Results show residential and commercial water systems have different characteristics associated with advisory status and length. For residential systems, certain governance structures are more likely to be placed on and to stay on advisory, especially the cooperative governance structures not operated by local governments. For commercial systems, administrative area and system size were associated with advisory status, but not advisory length. The overall results highlight the influence of governance structure and support the need for targeted interventions to improve residential small water systems not operated by local governments or utilities. Lastly, these results show how health officials can use administrative data for program planning and evaluation.

  1. Bioequivalence of generic drugs: a simple explanation for a US Food and Drug Administration requirement.

    PubMed

    Andrade, Chittaranjan

    2015-06-01

    There is a widespread misconception that for a generic drug to be deemed bioequivalent to a branded drug, it must contain 80%-125% of the active ingredient that is present in the branded version. More correctly, bioequivalence is studied in randomized crossover trials that compare the generic drug with the reference agent, and the relevant outcome measures are pharmacokinetic (PK) parameters such as peak drug concentration and area under the curve, which describe the rate and extent of absorption of the drug. The ratio of each PK characteristic of the generic drug to the reference drug is computed; the ideal value of this ratio is 1:1, or just 1.00 (indicating a perfect match, or perfect bioequivalence). Because this ideal is probably unattainable, the US Food and Drug Administration requires that the 90% confidence interval of the PK ratio should lie between 0.80 and 1.25. For the entire 90% confidence interval to meet this requirement, the mean PK value of the generic product should actually lie quite close to that of the reference standard. Therefore, the variation between the generic and the reference is actually small. These concepts are explained in this article with the help of simple, easy-to-understand examples. © Copyright 2015 Physicians Postgraduate Press, Inc.

  2. Use of Cough and Cold Medications in Severe Bronchiolitis Before and After a Health Advisory Warning against Their Use

    PubMed Central

    O’Donnell, Katherine; Mansbach, Jonathan M.; LoVecchio, Frank; Cheng, John; Piedra, Pedro A.; Clark, Sunday; Sullivan, Ashley F.; Camargo, Carlos A.

    2015-01-01

    We compared the use of cough and cold medications in two multicenter studies of young children hospitalized with bronchiolitis before and after the 2008 Food and Drug Administration cough and cold medications advisory. Although cough and cold medications use decreased after the advisory, nearly 20% of children age 12–23.9 months with severe bronchiolitis received cough and cold medications. PMID:25888349

  3. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee would be...

  4. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... Surgery Devices Panel of the Medical Devices Advisory Committee would be held on November 18, 2010. On...

  5. Use of Cough and Cold Medications in Severe Bronchiolitis before and after a Health Advisory Warning against Their Use.

    PubMed

    O'Donnell, Katherine; Mansbach, Jonathan M; LoVecchio, Frank; Cheng, John; Piedra, Pedro A; Clark, Sunday; Sullivan, Ashley F; Camargo, Carlos A

    2015-07-01

    We compared the use of cough and cold medications in 2 multicenter studies of young children hospitalized with bronchiolitis before and after the 2008 Food and Drug Administration cough and cold medications advisory. Although cough and cold medication use decreased after the advisory, nearly 20% of children age 12-23.9 months with severe bronchiolitis received cough and cold medications.

  6. 75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... agency's Web site and call the appropriate advisory committee hotline/phone line to learn about possible..., Inc., for the proposed indication of the treatment of hypoactive sexual desire disorder in...

  7. 78 FR 48174 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... last minute modifications that impact a previously announced advisory committee meeting cannot always... material available to the public no later than 2 business days before the meeting. If FDA is unable to post...

  8. 76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... the Agency's Web site and call the appropriate advisory committee hot line/phone line to learn about..., manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients...

  9. 77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-12

    ... patients with acute coronary syndrome (ACS) [ST elevation myocardial infarction (STEMI), non-ST elevation.../default.htm . Scroll down to the appropriate advisory committee link. Procedure: Interested persons may...

  10. 75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ..., for the proposed indication for use in acute coronary syndrome (including heart attacks and any of a.../Calendar/default.htm . Scroll down to the appropriate advisory committee link. Procedure: Interested...

  11. Use of data mining at the Food and Drug Administration.

    PubMed

    Duggirala, Hesha J; Tonning, Joseph M; Smith, Ella; Bright, Roselie A; Baker, John D; Ball, Robert; Bell, Carlos; Bright-Ponte, Susan J; Botsis, Taxiarchis; Bouri, Khaled; Boyer, Marc; Burkhart, Keith; Condrey, G Steven; Chen, James J; Chirtel, Stuart; Filice, Ross W; Francis, Henry; Jiang, Hongying; Levine, Jonathan; Martin, David; Oladipo, Taiye; O'Neill, Rene; Palmer, Lee Anne M; Paredes, Antonio; Rochester, George; Sholtes, Deborah; Szarfman, Ana; Wong, Hui-Lee; Xu, Zhiheng; Kass-Hout, Taha

    2016-03-01

    This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA). We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities. Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the US.

  12. The corporate assault on the Food and Drug Administration.

    PubMed

    Nixon, R

    1996-01-01

    Current "regulatory reform" in the U.S. Congress is seeking to eliminate the Food and Drug Administration. The author discusses the forces behind this reform and traces the impact of campaign contributions from various industries opposed to FDA regulations, stock held by members of Congress in companies regulated by the FDA, and a variety of organizations with ties to House Speaker Newt Gingrich that have received donations from industries that Gingrich has helped in their efforts to loosen FDA regulations. The article also examines the myth that the FDA is an overzealous watchdog imposing unnecessary burdens on the companies that it regulates. The controversy over the cow hormone rBGH is given as an example.

  13. 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.

  14. 78 FR 77687 - Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ..., the SAB will hear an update from each of NCTR's research Division's the Office of ] Science... HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...

  15. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel...

  16. 75 FR 60484 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... SPACE ADMINISTRATION NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics and Space Administration. ACTION: Notice of..., the National Aeronautics and Space Administration (NASA) announces a meeting of the Applied Science...

  17. Administrative detention of drugs intended for human or animal use. Final rule.

    PubMed

    2014-05-29

    The Food and Drug Administration (FDA or the Agency) is implementing administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA's administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain. Specifically, FDA is able to administratively detain drugs encountered during an inspection that an authorized FDA representative conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.

  18. A multifunctional pipette for localized drug administration to brain slices.

    PubMed

    Ahemaiti, Aikeremu; Ainla, Alar; Jeffries, Gavin D M; Wigström, Holger; Orwar, Owe; Jesorka, Aldo; Jardemark, Kent

    2013-10-15

    We have developed a superfusion method utilizing an open-volume microfluidic device for administration of pharmacologically active substances to selected areas in brain slices with high spatio-temporal resolution. The method consists of a hydrodynamically confined flow of the active chemical compound, which locally stimulates neurons in brain slices, applied in conjunction with electrophysiological recording techniques to analyze the response. The microfluidic device, which is a novel free-standing multifunctional pipette, allows diverse superfusion experiments, such as testing the effects of different concentrations of drugs or drug candidates on neurons in different cell layers with high positional accuracy, affecting only a small number of cells. We demonstrate herein the use of the method with electrophysiological recordings of pyramidal cells in hippocampal and prefrontal cortex brain slices from rats, determine the dependence of electric responses on the distance of the superfusion device from the recording site, document a multifold gain in solution exchange time as compared to whole slice perfusion, and show that the device is able to store and deliver up to four solutions in a series. Localized solution delivery by means of open-volume microfluidic technology also reduces reagent consumption and tissue culture expenses significantly, while allowing more data to be collected from a single tissue slice, thus reducing the number of laboratory animals to be sacrificed for a study.

  19. A multifunctional pipette for localized drug administration to brain slices

    PubMed Central

    Ahemaiti, Aikeremu; Ainla, Alar; Jeffries, Gavin D. M.; Wigström, Holger; Orwar, Owe; Jesorka, Aldo; Jardemark, Kent

    2013-01-01

    We have developed a superfusion method utilizing an open-volume microfluidic device for administration of pharmacologically active substances to selected areas in brain slices with high spatio-temporal resolution. The method consists of a hydrodynamically confined flow of the active chemical compound, which locally stimulates neurons in brain slices, applied in conjunction with electrophysiological recording techniques to analyze the response. The microfluidic device, which is a novel free-standing multifunctional pipette, allows diverse superfusion experiments, such as testing the effects of different concentrations of drugs or drug candidates on neurons in different cell layers with high positional accuracy, affecting only a small number of cells. We demonstrate herein the use of the method with electrophysiological recordings of pyramidal cells in hippocampal and prefrontal cortex brain slices from rats, determine the dependence of electric responses on the distance of the superfusion device from the recording site, document a multifold gain in solution exchange time as compared to whole slice perfusion, and show that the device is able to store and deliver up to four solutions in a series. Localized solution delivery by means of open-volume microfluidic technology also reduces reagent consumption and tissue culture expenses significantly, while allowing more data to be collected from a single tissue slice, thus reducing the number of laboratory animals to be sacrificed for a study. PMID:23969260

  20. 76 FR 78530 - Applications for Food and Drug Administration Approval To Market a New Drug; Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ...The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before......

  1. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... February 15, 2007'' to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  2. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  3. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  4. 28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will...

  5. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Pediatric Medical Devices... Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device...

  6. 76 FR 39884 - Aviation Security Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... SECURITY Aviation Security Advisory Committee AGENCY: Transportation Security Administration, DHS. ACTION... Security Administration (TSA) announces the re-establishment of the Aviation Security Advisory Committee... and cost, and have a lower impact on the commerce of aviation. The Aviation Security...

  7. 77 FR 46733 - Marine Fisheries Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ... National Oceanic and Atmospheric Administration RIN 0648-XC145 Marine Fisheries Advisory Committee AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce... of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will...

  8. 78 FR 3402 - Marine Fisheries Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... National Oceanic and Atmospheric Administration RIN 0648-XC443 Marine Fisheries Advisory Committee AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce... of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will...

  9. 76 FR 14379 - Marine Fisheries Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... National Oceanic and Atmospheric Administration RIN 0648-XA265 Marine Fisheries Advisory Committee AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce... of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will...

  10. 75 FR 17423 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug... Profession Schools, Inc. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... opportunities for socio-economically disadvantaged students. DATES: The agreement became effective January...

  11. 76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency's Compliance... availability; request for comments. SUMMARY: As part of the Transparency Initiative, the Food and Drug...

  12. 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...

  13. 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...

  14. 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...

  15. Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels.

    PubMed

    Wang, Bo; Canestaro, William J; Choudhry, Niteesh K

    2014-12-01

    Genetic biomarkers that predict a drug's efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add confusion to the clinical decision-making process. To evaluate the evidence that supports pharmacogenomic biomarker testing in drug labels and how frequently testing is recommended. Publicly available US Food and Drug Administration databases. We identified drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (ie, the ability to predict phenotype) and clinical utility (ie, the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention Working Group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision making. Of the 119 drug-biomarker combinations, only 43 (36.1%) had labels that provided convincing clinical validity evidence, whereas 18 (15.1%) provided convincing evidence of clinical utility. Sixty-one labels (51.3%) made recommendations about how clinical decisions should be based on the results of a biomarker test; 36 (30.3%) of these contained convincing clinical utility data. A full description of supporting studies was included in 13 labels (10.9%). Fewer than one-sixth of drug labels contained or referenced convincing evidence of clinical utility of biomarker testing, whereas more than half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data that link testing to patient outcomes do not exist.

  16. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) and (iii) of this section, the Commissioner will request the National Academy of Sciences to select...

  17. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical... communication of drug-drug interaction (DDI) information. FDA will seek input on: (1) Best practices in DDI... anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI...

  18. 21 CFR 14.31 - Consultation by an advisory committee with other persons.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Consultation by an advisory committee with other persons. 14.31 Section 14.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Commissioner as provided in paragraph (e) of this section. This paragraph (c) is not intended to bar...

  19. 21 CFR 14.31 - Consultation by an advisory committee with other persons.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Consultation by an advisory committee with other persons. 14.31 Section 14.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Commissioner as provided in paragraph (e) of this section. This paragraph (c) is not intended to bar...

  20. 21 CFR 14.31 - Consultation by an advisory committee with other persons.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Consultation by an advisory committee with other persons. 14.31 Section 14.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Commissioner as provided in paragraph (e) of this section. This paragraph (c) is not intended to bar...

  1. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) and (iii) of this section, the Commissioner will request the National Academy of Sciences to...

  2. 21 CFR 14.147 - Membership of a color additive advisory committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Membership of a color additive advisory committee. 14.147 Section 14.147 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... this section, the Commissioner will request the National Academy of Sciences to select the members of...

  3. Sources of meth. U.S. Drug Enforcement Administration (DEA).

    PubMed

    2005-01-01

    The Drug Enforcement Agency (DEA) maintains fact sheets on recent patterns of illegal drug sales and use in each state. Here are a few selected reports concerning methamphetamine that illustrate the diversity of sources for the drug.

  4. 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

  5. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Final rule.

    PubMed

    2009-07-28

    The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.

  6. 77 FR 42767 - Advisory Committee on Presidential Library-Foundation Partnerships

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-20

    ... RECORDS ADMINISTRATION Advisory Committee on Presidential Library-Foundation Partnerships AGENCY: National Archives and Records Administration. ACTION: Renewal of Advisory Committee on Presidential Library... the National Archives and Records Administration's (NARA) Advisory Committee on Presidential...

  7. 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.

  8. Caregivers' perception of drug administration safety for pediatric oncology patients.

    PubMed

    Harris, Nariman; Badr, Lina Kurdahi; Saab, Raya; Khalidi, Aziza

    2014-01-01

    Medication errors (MEs) are reported to be between 1.5% and 90% depending on many factors, such as type of the institution where data were collected and the method to identify the errors. More significantly, the risk for errors with potential for harm is 3 times higher for children, especially those receiving chemotherapy. Few studies have been published on averting such errors with children and none on how caregivers perceive their role in preventing such errors. The purpose of this study was to evaluate pediatric oncology patient's caregivers' perception of drug administration safety and their willingness to be involved in averting such errors. A cross-sectional design was used to study a nonrandomized sample of 100 caregivers of pediatric oncology patients. Ninety-six of the caregivers surveyed were well informed about the medications their children receive and were ready to participate in error prevention strategies. However, an underestimation of potential errors uncovered a high level of "trust" for the staff. Caregivers echoed their apprehension for being responsible for potential errors. Caregivers are a valuable resource to intercept medication errors. However, caregivers may be hesitant to actively communicate their fears with health professionals. Interventions that aim at encouraging caregivers to engage in the safety of their children are recommended.

  9. Raising suspicions with the Food and Drug Administration: detecting misconduct.

    PubMed

    Hamrell, Michael R

    2010-12-01

    The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.

  10. Annual Report of the National Advisory Committee for Aeronautics (1st). [Administrative Report Including Technical Reports Nos. 1 to 7

    NASA Technical Reports Server (NTRS)

    1916-01-01

    Report includes the National Advisory Committee for Aeronautics letter of submittal to the President, Congressional report, summaries of the committee's activities and research accomplished, expenditures, problems, recommendations, and a compilation of technical reports produced.

  11. Vaccines, Pharmaceutical Products, and Bioterrorism: Challenges for the U.S. Food and Drug Administration

    DTIC Science & Technology

    1999-08-01

    plague (Yersinia pestis), tularemia (Francisella tularensis), brucellosis ( Brucella abortus, B. melitensis , B. suis, B. canis), Q fever (Coxiella...Special Issue 20011029 090 Vaccines, Pharmaceutical Products, and Bioterrorism: Challenges for the U.S. Food and Drug Administration Kathryn C...Zoon U.S. Food and Drug Administration, Rockville, Maryland, USA In regards to bioterrorism, the goal of the U.S. Food and Drug Administration (FDA

  12. Approved drugs and their problems in patient care: routes of administration and dosing.

    PubMed

    Cook, Stuart D

    2007-08-15

    Problems in patient care with regard to route of administration and dosing of currently approved drugs are reviewed. Dose, frequency and route of administration can make a difference in efficacy, side effects, quality of life, antigenicity, cost, and compliance.

  13. Drug Enforcement Administration Western Lab wins EPA Federal Green Challenge award for electronics recycling

    EPA Pesticide Factsheets

    SAN FRANCISCO - Today, the U.S. Environmental Protection Agency Regional Administrator Jared Blumenfeld presented the Federal Green Challenge award to the Drug Enforcement Administration (DEA) Western Laboratory for increasing its electronics recycling mor

  14. 66 FR 9883 - NASA Advisory Council (NAC), Space Science Advisory Committee (SScAC), Structure and Evolution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2001-02-12

    ... and Evolution of the Universe Subcommittee AGENCY: National Aeronautics and Space Administration... Advisory Council, Space Science Advisory Committee, Structure and Evolution of the Universe Subcommittee...

  15. Dosage Form Developments of Nanosuspension Drug Delivery System for Oral Administration Route.

    PubMed

    Chen, Ang; Shi, Ye; Yan, Zhiqiang; Hao, Hongxun; Zhang, Yong; Zhong, Jian; Hou, Huiming

    2015-01-01

    A large amount of new drug candidates are practically insoluble in aqueous solvents and are even simultaneously poorly soluble in organic solvents. Nanosuspension drug delivery system (DDS) was firstly developed in 1994 and has attracted more and more attention as a formation solution for the poorly soluble drugs. By nansizing the poorly soluble drugs, nanosuspensions have several outstanding advantages for drug delivery. Among many administration routes of drug delivery, oral administration is the most preferred route due to its advantages such as ease of ingestion, versatility to accommodate various types of drug candidates, low production cost, high safety, good patient compliance, and pain avoidance. Current marketed pharmaceutical nanosuspension DDS products are mostly for oral administration. This review is to systematically summarize the nanosuspension DDS dosage form developments of poorly soluble drugs for oral administration use.

  16. 77 FR 63840 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees... to learn about possible modifications before coming to the meeting. Agenda: The committee will... with physical disabilities or special needs. If you require special accommodations due to a...

  17. 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 not...

  18. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  19. 76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... HUMAN SERVICES Food and Drug Administration Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA...

  20. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...