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Antidepressant drug manufacturers are being asked by the FDA to include warnings on product labeling recommending closer monitoring of adult and pediatric patients taking the drugs for worsening depression and suicidal thinking or behavior.
Wisconsin Gov. Jim Doyle should issue an additional disclaimer that drugs purchased through his state's reimportation website are not necessarily approved by U.S. regulators and may be unsafe, a top FDA official told the governor.
The Center for Biologics Evaluation and Research (CBER) has released details about the action plan it will implement when responding to reports of counterfeit drugs.
Saying the industry has failed to give it sufficient input, the FDA last week reopened the comment period for a notice on time estimates for collecting information for reporting manufacturing changes on approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
In an effort to speed up the drug-development process, the FDA last week proposed a series of initiatives to encourage drugmakers and academic institutions to collaborate with the agency on removing obstacles along the development path so that innovative products can reach patients as quickly and as inexpensively as possible.
The consumer advocacy group Public Citizen last week filed suit against the FDA, alleging the agency ignored the group’s petition a year ago asking for a ban on the antidepressant drug nefazodone, which is marketed by Bristol-Myers Squibb (BMS) as Serzone.
Contract manufacturer Andersen Pharmaceuticals has been warned by the FDA that labeling for one of its astringent products is not only out of compliance with the OTC monograph for the products, but that batch production records at the firm's Norwich, N.Y., facility are also deficient in four areas.
The FDA’s Obesity Working Group (OWG) has told the agency it should update an 8-year-old draft guidance on weight loss drugs to address newer long-term therapies and to advance an HHS campaign to alleviate the obesity epidemic in the U.S.
Even as members of Congress and the Bush administration engage in their increasingly loud rhetorical battle over reimportation, a flood of illegal prescription drugs is quietly washing through the nation’s mail facilities every day.