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Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
Valeant Pharmaceuticals is defending its business relationship with specialty pharmacy Philidor RX Services against allegations Valeant used it to inflate financial results. Read More
In a conflicted decision with most members suggesting postmarketing studies, an FDA advisory panel voted 10 to four Friday to recommend approval of AstraZeneca’s gout drug lesinurad. Read More
The FDA and European Medicines Agency took differing views on multiple melanoma injections up for approval, with the U.S. agency rejecting Spectrum Pharmaceuticals’ Evomela and the EMA’s scientific experts recommending approval of Amgen’s Imlygic. Read More
The FDA Friday approved Alexion Pharmaceuticals’ Strensiq for the first-ever treatment of hypophosphatasia, a rare genetic metabolic disorder that weakens bones. Read More
FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More