Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA

5 October 2022 — FDA published the final guidance on formal meetings between FDA and ANDA applicants for industry.

This guidance provides recommendations to industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) between FDA and abbreviated new drug application (ANDA) applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance is intended to provide procedures that will promote well-managed post-CRL clarification teleconferences and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).

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