ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

2 December 2022 – the FDA published the draft guidance on the abbreviated new drug applications (ANDAs) for industry.

The FDA is issuing this revised draft guidance to incorporate program enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC) within the abbreviated new drug application (ANDA) assessment program agreed upon by the Agency and industry as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA III), as described in GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter).

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