FDA Issues Draft Guidance for Post-CRL Procedures in ANDA Applications
The US Food and Drug Administration (FDA) has issued draft guidance, Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA, to help applicants understand how to best respond to Complete Response Letters (CRLs) from the FDA.
The draft guidance provides recommendations on post-CRL meetings between the FDA and abbreviated new drug application applicants for the purpose of clarifying deficiencies identified in a CRL. The draft guidance was released to complement time-frame commitments set out in the Generic Drug User Fee Amendments of 2017 (GDUFA II), which reauthorized generic-drug user fees for fiscal years 2018-2022.
The draft guidance recommends that a post-CRL meeting request include: (1) a list of proposed questions seeking clarification of the deficiencies identified in the CRL, grouped by discipline; (2) a list of proposed questions seeking clarification of the deficiencies identified in the CRL, grouped by discipline; (3) the requested format of the meeting—teleconference or written response. If the requested format of the meeting is a teleconference, the meeting request package should also include the following information: a proposed agenda outlining how the 30-minute time allotted for the post-CRL meeting should be apportioned to each proposed question and a list of specific review disciplines asked to participate in the requested teleconference.
The draft guidance further specifies that a post-CRL meeting request may be granted if one of the following conditions exist: a post-CRL meeting request has not already been submitted for the same CRL, the proposed questions seek clarification concerning deficiencies in the CRL, or a complete meeting package is submitted.
In addition, the draft guidance says the FDA will grant or deny a post-CRL meeting request for written responses within 10 calendar days of receipt of a written request, and the applicant will be notified in writing. If the post-CRL meeting request is granted, the FDA will provide written responses within 30 days of receipt of a post-CRL meeting request requesting a written response. The FDA will grant one post-CRL meeting request per CRL, covering only questions submitted in a single complete post-CRL meeting request package.