U.S. FDA advisory meetings through Aug 13
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.
DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE
DATE: June 26, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Paul Tran, 301-827-7001
The committee will discuss a new drug application from Ista Pharmaceuticals (ISTA.O) for Bepreve (bepotastine besilate) ophthalmic solution, 1.5%, for the treatment of ocular itching associated with allergic conjunctivitis, and a new drug application from River Plate Biotechnology Inc for sodium hyaluronate ophthalmic solution for the treatment of the signs and symptoms of dry eye disease. Alcon Inc (ACL.N) holds U.S. marketing rights to River Plate's product.
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE WITH THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
DATE: June 29-30, 0800/1200
LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committees will discuss how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter and prescription products.
ONCOLOGIC DRUGS ADVISORY COMMITTEE
DATE: July 15, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Nicole Vesely, 301-827-6793 Continued...
