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The inability of the FDA to keep pace with the rapidly advancing pharmaceutical industry has left it with a wide array of problems, particularly on the drug safety front, asserts Eve Slater, former assistant secretary for health at HHS.
The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), will release its “GAMP Good Practice Guide: Risk Management Approach to Electronic Records and Signatures,” on Feb. 18 at an ISPE conference in Tampa, Fla.
The head of the FDA’s embattled Office of Drug Safety (ODS) acknowledged there are gaps in the agency’s postmarketing surveillance system for prescription drugs, but he vigorously defended the office’s record in monitoring marketed products and denied that the FDA drug safety group is under anybody’s thumb.
A key objective of the FDA’s Office of Drug Safety (ODS) in fiscal 2003 was to develop a more cohesive working relationship with the review division staff in the Office of New Drugs (OND), according to ODS, which has come under attack recently for allegedly being too close to OND.
An FDA advisory committee has recommend the FDA not approve Procter & Gamble’s (P&G’s) experimental drug to treat low sexual desire in women who have become menopausal following surgery and are also on estrogen therapy.
To protect patients from taking fake versions of a popular drug product, Pfizer has announced plans to add radio-frequency identification (RFID) tags to all packages of Viagra sold in the U.S. by the end of next year.
The FDA has announced that black box labeling for Danco Laboratories’ Mifeprex will be revised to reflect serious complications in patients taking the drug, including at least two deaths.
Pfizer has announced it will add radio-frequency identification (RFID) tags to all packages of Viagra sold in the U.S. by the end of next year to protect patients against the risk of ingesting counterfeit versions of the drug.
The FDA will commission the Institute of Medicine (IOM) to evaluate the U.S. drug safety system and assess the FDA's role in delivering safe and effective drugs to the public, the agency announced yesterday.
In an effort to ensure the quality and safety of dietary supplements, the FDA plans to implement an "umbrella strategy" that focuses on monitoring the quality of products, labels and ingredients.