Friday February 6, 05:46 PM
U.S. FDA advisory meetings through March 5
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EST/GMT.
JOINT MEETING OF THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY
COMMITTEE
DATE: Jan 30, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Kalyani Bhatt, 301-827-7001
The committee will discuss the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid (HCL), napsylate salts and combination drugs) and whether any regulatory action is appropriate.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: Feb 3, 0800/1300
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committee will discuss a new drug application for Eli Lilly and Daiichi Sankyo (DSKYF.PK - news) 's prasugrel hydrochloride film coated oral tablets, 5 milligrams and 10 milligrams, for the proposed indication for use in acute coronary syndrome.
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
DATE: Feb 4, 0830/1230
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss a biologics license application from Dyax Corp (NASDAQ: DYAX - news) for ecallantide injection for the proposed indication of treatment of acute attacks of hereditary angioedema.
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
DATE: Feb 18-19, 0830/1230
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Christine Walsh, 301-827-0314
On Feb. 18, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2009 - 2010 influenza season. In the afternoon, it will discuss the utility of adding a second B strain to current seasonal influenza vaccines.
On Feb. 19, the committee will discuss clinical studies of pandemic influenza vaccine in the children in the absence of an influenza pandemic.
MEETING OF THE RISK COMMUNICATION ADVISORY COMMITTEE
DATE: Feb 26-27, 0800/1300
LOCATION: National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594
CONTACT: Lee Zwanziger, 301-827-2895
On both days there will be a discussion of different types of prescription drug information currently available to patients in the form of Medicating Guides, Patient Package Inserts, and Consumer Medication Information.
ARTHRITIS ADVISORY COMMITTEE
DATE: March 5, 0830/1230
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Nicole Vesely, 301-827-6793
The committee will discuss a biologics license application from Savient Pharmaceuticals Inc (NASDAQ: SVNT - news) for pegloticase as a therapy for patients with treatment failure gout.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY
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