FDA updates guidance for Reconsideration of Regulatory actions for ANDAs

This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration on a FDA decision or action related to ANDAs. Regulatory actions eligible for a request for reconsideration include

• Refuse-to-receive decision
• Tentative approval letter
• Complete response letter (CRL)
• FDA determination that a supplement-changes being effected or a supplement-changes being effected in 30 days is a prior approval supplement (PAS)
• Classification of a major amendment to an ANDA or PAS 
• Classification of the standard assessment status of an ANDA, ANDA amendment, PAS, or PAS amendment
• Denial of a reclassification of a facility-based major CRL amendment
• Denial of a pre-ANDA meeting

During the assessment of an ANDA, an applicant may disagree with the decision or action of FDA. These can be taken up for a reconsideration with FDA at the division level or original signatory authority. Applicant should submit the request for reconsideration within 7 calendar days from the date of the regulatory action taken by FDA. However, the guidance clarifies that matters like advice communicated during meetings or teleconferences with FDA are not regulatory action taken by FDA and would not be appropriate for a request for reconsideration. The guidance also recommend applicant to request meetings with FDA for post CRL clarifications under GDUFA III before submitting a request for reconsideration.

The guidance also clarify that applicants shall not submit any new information as part of request for reconsideration. If applicant want FDA to consider any new information, applicant should submit it as an amendment to an ANDA or a PAS. Also, an applicant submitting a request for reconsideration should not be actively engaging with other entities within FDA or pursue other regulatory or legal pathways on the same matter at the same time as it could impede FDAs consideration of a request for reconsideration.

The guidance advices on the Content and Format of a Request for Reconsideration, which should include brief comprehensive statement of each matter to be resolved, list of documents previously submitted and a statement that no new information is being submitted along with request for reconsideration along with other administrative information.

Requests for Reconsideration at the Division Level Under GDUFA – Guidance (January 2024)