Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry

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Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry
  • Appropriate Matter for a Request for Reconsideration?
  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.
  • Not Appropriate for a Request for Reconsideration?
  1. Advice provided during meetings or teleconferences, in meeting minutes, or through other forms of correspondence (such as information requests or discipline review letters) does not constitute a regulatory action by the FDA. As a result, it is not appropriate for an applicant to submit a request for reconsideration based on such advice.
  2. Matters that are not suitable for reconsideration by an applicant include, but are not limited to, general advice letters and advice shared during meetings or in meeting minutes related to discussions of generic drug development prior to the submission of an ANDA.
  • The applicant should not submit new information as part of a request for reconsideration.
  • As per GDUFA III commitment letter, for requests to “reclassify a Major Amendment or standard assessment status, FDA will schedule and conduct teleconference and decide 90 percent of such reclassification requests within 30 days of the date of FDA’s receipt of the request for a teleconference.
  • Applicant should submit request for reconsideration with 7 calender days from the regulatory action taken by FDA for the 30-day goal period.
  • If an applicant would like to submit request for reconsideration of the classification of the deficiencies in the CRL as major, assessment classification of a major amendment and assessment classification a standard assessment status, the applicant need to submit request for reconsideration within 7 calendar days from the FDA acknowledgment letter to receive FDA GDUFA goal date.
  • If applicant has not submit within 7 calendar days, applicant will not receive a GDUFA III goal date.
  • The content and format for request for reconsideration is form, cover letter, Established name of drug product, brief comprehensive text which includes Description of eligibility, summary of regulatory history, applicant proposed possible solutions and outcome.
  • If applicant requesting the request for reconsideration via teleconference the request should include all the individuals and titles of their affiliations.
  • To submit request for reconsideration for Pre-ANDA meetings we need to drop a mail to ANDAReconsideration@fda.hhs.gov.
  • For requests for reconsideration of a determination made by the Division of Filing Review for refuse-to-receive decisions and for all other considerations, applicant need to request a separate amendment to the ANDA.
  • Based on eligibility criteria the division of filing review and project manager will conduct the preliminary review of applicant’s request for reconsideration can be accepted and provide the acknowledgement letter. If it is denied the division of filing review or project manager should provide the reasons for not agreeing.
  For complete details, refer guidance – Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry https://www.fda.gov/media/108398/download
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