FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

The FDA issued a draft guidance on November 18 titled “Frequently Asked Questions: Developing Potential Cellular and Gene Therapy Products.” This guidance aims to assist

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA. This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023- 2027” (GDUFA III commitment letter). Specifically, this guidance describes instances when an early assessment or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which FDA would commence an early assessment of Type II API DMFs 6 months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request. The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), submissions related to ANDAs that are not described above, or any other types of DMFs.