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USFDA Guidance: Requests for Reconsideration under GDUFA

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance "Requests for Reconsideration at the Division Level Under GDUFA" that details the recommendations on the procedures to be followed by applicants of abbreviated new drug applications (ANDAs) who wish to pursue a request for reconsideration within the review discipline at the division level or with the original signatory authority.

FDA's procedures and policies are described in this guidance to formalize their current practices and to ensure that applicant requests are resolved rapidly and fairly.

What Is an Appropriate Matter for a Request for Reconsideration?

Regulatory actions related to ANDAs and having scientific significance can be handled appropriately by requesting reconsideration from the FDA. Regulatory actions that are appropriate for a request for reconsideration include, but are not limited to:

  1. Refuse-to-receive decision

  2. Tentative approval letter

  3. Complete response letter (CRL)

  4. FDA determination that a supplement-changes being effected or a supplement-changes being effected in 30 days is a prior approval supplement (PAS)

  5. Classification of a major amendment to an ANDA or PAS

  6. Classification of the standard assessment status of an ANDA, ANDA amendment, PAS, or PAS amendment

  7. Denial of a reclassification of a facility-based major CRL amendment

  8. Denial of a pre-ANDA meeting

A request for reconsideration by an applicant is not appropriate in cases such as general advice letters, advice communicated during meetings, or advice recorded in meeting minutes to discuss generic drug development before ANDA submission (pre-ANDA meetings), including meetings for complex generic drug products noted in the commitment letter to GDUFA III.

To know more elaborately on the Timelines for Responding to Requests for Reconsideration, How to Submit a Request for Reconsideration, Content and Format of a Request for Reconsideration, etc click this LINK.


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