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The FDA is calling for a regulatory meeting with Respironics to determine why the Carlsbad, Calif.-based manufacturer repeatedly failed to submit medical device reports (MDRs) in connection with defective check valves on its Espirit ventilator.
Questions about the source of clinical trial data submitted by Dr. Reddy’s have caused the FDA to take another look at the company’s new drug application (NDA) for a generic version of Pfizer’s hypertension and angina drug Norvasc.
The General Accounting Office (GAO) intends to issue its opinion on allegations the Bush administration violated the law by misusing taxpayer money in its advertising campaign for the new Medicare law around the end of March, a GAO spokesperson said last week.
The makers of hormone therapy (HT) products need to revise their labeling to include data from a clinical study that found women over 65 had an increased risk of dementia when taking oral conjugated estrogens plus medroxyprogesterone acetate, the FDA said last week.
Drugmakers requested by a regulatory authority to file product information that spans several periodic safety update reports (PSURs) should file a summary bridging report (SBR), the FDA announced in a final International Conference on Harmonisation (ICH) guidance released last week.
A health advocacy group is demanding that the FDA remove three members of its Psychopharmacologic Advisory Committee who had done research, consulting and other work for manufacturers of antidepressant drugs, even though the committee recently urged the agency to issue stronger warnings about increased suicide risk among children taking those drugs.
Citing the potential far-reaching impact of the decision, the FDA said last week that it will appeal a court ruling overturning the agency’s decision to grant shared 180-day exclusivity to several generic firms seeking to market a version of GlaxoSmithKline’s depression drug Paxil (paroxetine HCl).
Some critics are wondering whether the FDA has the time and people the agency needs to process the additional data it is requesting in its proposed rule on in vivo bioequivalence (BE) data submitted in abbreviated new drug applications (ANDAs).
Exercising for the first time its authority under the 1994 Dietary Supplement Health and Education Act (DSHEA), the FDA has banned dietary supplements containing ephedra because of safety concerns, the agency said when releasing the final rule. The ban takes effect April 12.
An FDA mandate requiring companies to switch to a new file format when submitting drug-label changes will almost certainly cause some short-term pain for the industry, but that should be offset by long-term gains in flexibility and uniformity, according to some industry experts.