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ARTICLE | Politics & Policy

Aug. 16 Politics & Policy Quick Takes: FDA's guidance for gastroparesis and plan to purge outdated drug listings; plus generics price fixing allegations

August 17, 2019 12:05 AM UTC

FDA updates gastroparesis guidance
FDA released draft guidance to help develop therapies for idiopathic and diabetic gastroparesis. The guidance offers strategies to incorporate patient-reported outcome measures into clinical trials as well as recommendations for trial endpoints. FDA is accepting public comments until Oct. 14.

Agency to inactivate old drug listings
FDA announced plans to inactivate and remove outdated drug listing records in its database by Sept. 12. The agency has asked companies to review and update any inaccurate active drug listing submissions, and reminded sponsors they are to update or certify drug listing data twice a year in June and December...