Neurological Devices Panel of the Medical Devices Advisory Committee
Meeting on March 18, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On March 18, 2011, the committee will discuss, make recommendations and vote on information related to the PMA for the Pipeline Embolization Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the paraclinoid region of the internal carotid artery.
Tuesday, February 8, 2011
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
Meeting on March 17, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On March 17, 2011, the committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the NovoTTF-100A Treatment Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A Treatment Kit is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra-tentorial region of the brain. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy for GBM.
Meeting on March 17, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On March 17, 2011, the committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the NovoTTF-100A Treatment Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A Treatment Kit is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra-tentorial region of the brain. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy for GBM.
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.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on March 17 and 18 2011, from 8 a.m. to 5 p.m.
Agenda: On March 17 and 18, 2011, the committee will continue to receive updates from the Menthol Report Subcommittee and discuss plans for finalizing the report regarding the impact of use of menthol in cigarettes on the public health.
Committee Meeting on March 17 and 18 2011, from 8 a.m. to 5 p.m.
Agenda: On March 17 and 18, 2011, the committee will continue to receive updates from the Menthol Report Subcommittee and discuss plans for finalizing the report regarding the impact of use of menthol in cigarettes on the public health.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on March 1 and 2 2011, from 8 a.m. until 5 p.m.
Agenda: On March 1 and 2, 2011, the Committee will continue to (1) receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 and 31, 2010, meeting of the Tobacco Products Advisory Committee.
Committee Meeting on March 1 and 2 2011, from 8 a.m. until 5 p.m.
Agenda: On March 1 and 2, 2011, the Committee will continue to (1) receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 and 31, 2010, meeting of the Tobacco Products Advisory Committee.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
Committee Meeting on March 8 and 9 2011, from 8:00 a.m. to 6:00 p.m.
Agenda: On March 8 and 9, 2011, the committee will discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims.
Committee Meeting on March 8 and 9 2011, from 8:00 a.m. to 6:00 p.m.
Agenda: On March 8 and 9, 2011, the committee will discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims.
Tuesday, February 1, 2011
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Committee Meeting on March 2, 2011, from 7:15 a.m. to 3 p.m.
Agenda: The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases
Committee Meeting on March 2, 2011, from 7:15 a.m. to 3 p.m.
Agenda: The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases
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