Gastrointestinal Drugs Advisory Committee
DATE: January 12, 2011 TIME: 8:00 a.m. to 5:00 p.m.
LOCATION: Great Room, FDA, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993 CONTACTS: Kristine T. Khuc, Pharm.D., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, WO31-2417, Silver Spring, MD 20993-0002, 301-796-9001.
The committee will discuss the safety and efficacy of new drug application (NDA) 022486, 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.
Peripheral and Central Nervous System Drugs Advisory Committee
DATE: January 20-21, 2011
TIME: Day 1, 8:00 a.m. to 5:00 p.m.
Day 2, 8:00 a.m. to 12:00 noon
LOCATION: Great Room, FDA, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993 CONTACT: Diem-Kieu Ngo, Center for Drug Evaluation and Research , Food and Drug Administration, WO31-2417, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, 301-796-9001.
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 β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease.
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.
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.
Neurological Devices Panel of the Medical Devices Advisory Committee
DATE: January 27-28, 2011
TIME: Day 1, 8:00 a.m. to 6:00 p.m.
LOCATION: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD.
CONTACT: James Engles, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area)
The committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.Oncologic Drugs Advisory Committee
DATE: February 9, 2011
TIME: 8:00 a.m. to 12:30 p.m.
LOCATION: Great Room, FDA, White Oak Campus, Bldg. WO-31, 10903 New Hampshire Ave., Silver Spring, MD 20993
CONTACT: Nicole Vesely, Pharm.D., Food and Drug Administration, 10903 New Hampshire Avenue WO31-2417, Silver Spring, Maryland 20993-0002, Phone: 301-796-9001, E-mail: Nicole.Vesely@fda.hhs.gov
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.
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