FDA’s CDER un­veils de­tails of re­or­ga­ni­za­tion

The US Food and Drug Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) on Thurs­day an­nounced the de­tails of a ma­jor re­or­ga­ni­za­tion, af­fect­ing near­ly one-third of CDER.

The pro­posed re­or­ga­ni­za­tion will im­pact the Of­fice of New Drugs, Of­fice of Com­pli­ance, Of­fice of Ex­ec­u­tive Pro­grams, and Of­fice of Com­mu­ni­ca­tions and has been sub­mit­ted to HHS, though still must be ap­proved by HHS and sub­mit­ted to Con­gress for con­cur­rence. The changes will be in ef­fect once ap­proval is re­ceived and the 30-day con­gres­sion­al no­ti­fi­ca­tion has lapsed, FDA said.

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