Food Advisory Committee

Food Advisory Committee

Committee Meeting on March 30 and 31, 2011 from 8:00 a.m. to 4:30 p.m.

Agenda: The Food Advisory Committee will meet to discuss whether available relevant data demonstrate a link between children''''s consumption of synthetic color additives in food and adverse effects on behavior.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

Committee Meeting on February 9, 2011, from 8 a.m. to 12:30 p.m.

Agenda: On February 9, 2011, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY(ipilimumab), submitted by Bristol-Myers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee

Committee Meeting on January 27 and 28, 2011 from 8:00 a.m. to 6:00 p.m.

Agenda: On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee

Committee Meeting on January 21, 2011, from 8 a.m. to 12 p.m.

On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee
Committee Meeting on January 20, 2011, from 8 a.m. to 5 p.m.

Agenda: On January 20, 2011, the committee will discuss new drug application (NDA) 202-008,florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of [beta]-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer''s disease.

Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee

Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee

Committee Meeting on Wednesday, January 19, 2011, from 7:30 a.m. to 4:30 p.m.

SUMMARY: This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute.

Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee

Committee Meeting on January 12, 2011, from 8 a.m. to 5:00 p.m.

Agenda: On January 12, 2011, the committee will discuss the safety and efficacy of new drug application (NDA)022–486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas. The pancreas is an organ involved, in part, in the digestion of food through the use of specialized proteins called enzymes. Exocrine pancreatic insufficiency is a decreased ability to digest food due to deficient enzyme production by the pancreas.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee

Committee Meeting on January 10th and 11th 2011, from 8 a.m. to 5:00 p.m.

Agenda: On January 10 and 11, 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 Scientific Advisory Committee.