Microbiology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Tuesday, March 22, 2011
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Committee Meeting on May 18, 2011, from 8 a.m. to 12:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Committee Meeting on May 18, 2011, from 8 a.m. to 12:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee
Committee Meeting on May 17, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Committee Meeting on May 17, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
Allergenic Products Advisory Committee
Allergenic Products Advisory Committee
Committee Meeting on May 12, 2011, from 8 a.m. to approximately 3:30 p.m.
Agenda: On May 12, 2011, in open session, the committee will receive updates and have discussion on the following topics: (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.
Committee Meeting on May 12, 2011, from 8 a.m. to approximately 3:30 p.m.
Agenda: On May 12, 2011, in open session, the committee will receive updates and have discussion on the following topics: (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.
Blood Products Advisory Committee
Blood Products Advisory Committee
Committee Meeting on April 29, 2011, from 8:00 a.m. to 1 p.m. Day 2 of 2
Agenda: On April 29, 2011, in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services'''' Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.
Committee Meeting on April 29, 2011, from 8:00 a.m. to 1 p.m. Day 2 of 2
Agenda: On April 29, 2011, in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services'''' Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.
Blood Products Advisory Committee
Blood Products Advisory Committee
Committee Meeting on April 28, 2011, from 8:30 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, in the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing.
Committee Meeting on April 28, 2011, from 8:30 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, in the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing.
Antiviral Drugs Advisory Committee
Antiviral Drugs Advisory Committee
Committee Meeting on April 28, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Committee Meeting on April 28, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Antiviral Drugs Advisory Committee
Antiviral Drugs Advisory Committee
Committee Meeting on April 27, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Committee Meeting on April 27, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on April 27, 2011, from 8 a.m. to 6 p.m.
Agenda: On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.
Committee Meeting on April 27, 2011, from 8 a.m. to 6 p.m.
Agenda: On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Committee Meeting on April 12, 2011, from 8:00 a.m. to 5:00 p.m.
Agenda: On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S-009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication(use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET)of gastrointestinal, lung, or pancreatic origin.
During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).
Committee Meeting on April 12, 2011, from 8:00 a.m. to 5:00 p.m.
Agenda: On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S-009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication(use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET)of gastrointestinal, lung, or pancreatic origin.
During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).
Vaccines and Related Biological Products Advisory Committee, Day 2 of 2
Vaccines and Related Biological Products Advisory Committee, Day 2 of 2
Committee Meeting on April 7, 2011, between approximately 8:30 a.m. and 3:30 p.m.
Agenda: On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.
Committee Meeting on April 7, 2011, between approximately 8:30 a.m. and 3:30 p.m.
Agenda: On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.
Vaccines and Related Biological Products Advisory Committee, Day 1 of 2
Vaccines and Related Biological Products Advisory Committee, Day 1 of 2
Committee Meeting on April 6, 2011, between approximately 9 a.m. and 4 p.m.
Agenda: On the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A, C, Y, and W-135 conjugate vaccines administered to children less than 2 years of age.
Committee Meeting on April 6, 2011, between approximately 9 a.m. and 4 p.m.
Agenda: On the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A, C, Y, and W-135 conjugate vaccines administered to children less than 2 years of age.
Anti-Infective Drugs Advisory Committee
Anti-Infective Drugs Advisory Committee
Committee Meeting on April 5, 2011, from 8:30 a.m. to 4:00 p.m.
Agenda: On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
Committee Meeting on April 5, 2011, from 8:30 a.m. to 4:00 p.m.
Agenda: On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
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