On December 3, 2018, FDA issued final guidance on Post-Complete Response Letter (CRL) Meetings between FDA and ANDA Applicants under GDUFA. The guidance provides recommendations to industry on post-CRL meetings between FDA and ANDA applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the FDCA. FDA defines a post-CRL meeting as a meeting requested in writing by an ANDA applicant pursuant to procedures described in the guidance following receipt of a CRL. This guidance is intended to provide procedures that will promote a well-managed post-CRL meeting.
FDA will grant any complete post-CRL meeting request that satisfies the criteria outlined in section IV of the guidance. The written request should be submitted to the ANDA via Electronic Submissions Gateway within 10 calendar days of issuance of the CRL. Any post-CRL meeting request should include the following information:
- A list of proposed questions seeking clarification of the deficiencies identified in the CRL, grouped by discipline;
- A list of all individuals who will participate in the requested meeting from the applicant’s organization and consultants; and
- The requested format of the meeting, i.e., teleconference or written response, along with the required additional information for that format.
The guidance further specifies the grant and denial process of the post-CRL meeting request, as well as the action to be taken by FDA or requestor following the decision.
Readers are encouraged to read the final guidance, also available on FDA’s website.
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