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The FDA announced in a final International Conference on Harmonisation (ICH) guidance that drugmakers that have been requested by a regulatory authority to file product information that spans several periodic safety update reports (PSURs) should file a summary bridging report (SBR).
Guidance documents on product labeling, advertising, botanical drugs and a variety of other topics have been released by the FDA this year, but so far no guidance on follow-on biologics is available.
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a warning letter to GlaxoSmithKline (GSK), citing the company for false and misleading claims about three of its hepatitis vaccinations, as well as a non-GSK influenza vaccine.
Current and former FDA officials, as well as Republican lawmakers, are defending the FDA’s Office of Chief Counsel (OCC), asserting that the agency is empowered by federal law to intervene on behalf of drugmakers in consumer lawsuits and asking that the office not be penalized for doing so.
While patent challenges to billion-dollar drugs garner the headlines, the FDA has been quietly approving scores of generic applications targeting drugs for which patents are not being contested.
Barr Pharmaceuticals has resubmitted an application seeking approval for an OTC version of its emergency oral contraceptive, Plan B, which the FDA rejected this spring against the favorable recommendations of a scientific advisory panel.
Purported generic versions of three popular Rx drugs purchased from a website advertised as Canadian revealed the products to be potentially dangerous, according a recent FDA investigation.
The FDA has denied a citizen petition by a health advocacy group calling for the removal of Bristol-Myers Squibb’s (BMS’) antidepressant Serzone because of safety concerns — a move that allows generic firms to continue to market the drug, which no longer is sold by BMS.
Mylan Pharmaceuticals is seeking an emergency court order to block the FDA’s recent decision to withdraw final approval for Mylan’s version of Janssen Pharmaceutica’s profitable pain-drug patch, Duragesic.
The FDA has refused to prohibit the marketing and distribution of brand-authorized generic drugs during another generic firm’s 180-day exclusivity period for the same product — a move that will likely prompt a lawsuit against the agency.