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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
There is no compelling reason, according to the petition, why the FDA should not approve generic competitors’ ANDAs as long as they meet accepted quality standards. Read More