ANDA Submissions – Prior Approval Supplements Under GDUFA

14 October 2022 — FDA published final guidance on ADNA submissions for industry.

This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

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