Occasionally, applicants may disagree with an FDA decision regarding one of their submissions. A recent guidance published by the U.S. Food and Drug Administration covers its procedures to ensure the open and quick evaluation of the applicant’s concerns. This article provides an overview of what can be pursued for a request for reconsideration and its submission process.
What can be submitted for a request for reconsideration?
A request for reconsideration can be sent for FDA regulatory actions such as a refuse-to-receive decision, a tentative approval letter, a complete response letter (CRL), a denial of a pre-ANDA meeting, a denial of reclassification of a facility-based major CRL amendment, a classification of an ANDA or PAS major amendment or standard assessment status, among others.
Advice given during in-person or online meetings, minutes, information requests, or discipline review letters cannot be submitted for reconsideration as they are not considered FDA regulatory actions.
But what if an applicant wishes to submit new information as part of their reconsideration request? Since the FDA must make decisions based on the information attached to the original ANDA filing, an applicant must submit new information as an amendment to review it.
How to submit a request for reconsideration to the FDA
The process of requesting a reconsideration depends on what needs to be re-evaluated:
For denial of a pre-ANDA meeting, the applicant must submit the request to the project manager identified in the communications that needs to be reconsidered and copy it to ANDAReconsideration@fda.hhs.gov.
For determinations made by the Division of Filing Review: the applicant should submit the request as an ANDA amendment, clearly identifying on the cover letter or checklist that a request for reconsideration is attached. The applicant should email a copy to ANDAReconsideration@fda.hhs.gov and the Division of Filing Review at DFRSupervisor@fda.hhs.gov.
For all other requests: the applicant should submit an ANDA amendment, mentioning that there is a request for reconsideration in the cover letter or checklist, and email a copy to ANDAReconsideration@fda.hhs.gov and to the project manager identified in the communication that is submitted for reconsideration.
The most important to consider is that time is essential when requesting a reconsideration, as it needs to be submitted within 7 calendar days from the date in which the FDA took regulatory action.
Once the FDA receives a request, it will evaluate it as soon as possible. In the case of reclassification of a major amendment or standard assessment, the FDA will decide within 30 days in 90% of the cases. This timeline applies only if the applicant accepts the first teleconference date suggested by the FDA.
Asking the FDA to reconsider a decision requires the applicant to understand the eligible actions, submission procedures, and critical deadlines. By doing so, the applicants show their willingness to learn and adhere to regulatory compliance, which over time could lead to less (or even none) need to submit requests for reconsideration.
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