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A Pennsylvania district court refused to certify a group of corporate and institutional drug purchasers as plaintiffs in a class-action antitrust suit against several drugmakers — saying the approximately two-dozen organizations in the class was relatively small and did not meet legal class-action requirements. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More
CDER is currently conducting research to determine the effectiveness of limiting the risks in the major statement to the most severe, serious or actionable. Read More
A federal task force to study pain management and prescription painkillers should get under way soon, HHS said in a Federal Register filing Monday. Read More
FDA Commissioner Scott Gottlieb announced moves to crack down on illicit marketers of stem-cell therapies while also pledging to foster ethical innovation in the field. Read More
The FDA released updated GDUFA program fees for the 2018 fiscal year that come with a big hike in ANDA fees and include, for the first time, annual fees for ongoing marketing of approved generics. Read More