Meeting With FDA After a CRL: Draft Guidance on What to Expect
Posted 13 October 2017 | By
The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.
The guidance, released as part of the agency's second Generic Drug User Fee Amendments (GDUFA II) commitments, offers details for companies on what a meeting request should include, how the requests will be assessed, the procedures for conducting meeting teleconferences, the documentation of meetings and resolution of disputes about meeting minutes.
Under the first GDUFA, which came to an end on 30 September 2017, FDA committed to close out a certain number of teleconference requests in fiscal year (FY) 2015 through FY 2017. But thanks to GDUFA II, the agency has committed to providing a scheduled date for 90% of post-CRL meetings within 10 calendar days of receipt of a written request, and to conducting 90% of post-CRL meetings held on an FDA-proposed date within 30 days of receipt of a written request.
How to Request a Meeting
The draft guidance notes that a complete post-CRL meeting request package should include:
- "A list of proposed questions seeking clarification of the deficiencies identified in the CRL, grouped by discipline.
- A list of all individuals, with their titles and affiliations, who will attend the requested meeting from the applicant's organization and consultants.
- The requested format of the meeting—teleconference or written response. If 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. A list of specific review disciplines asked to participate in the requested teleconference."
FDA also says that a post-CRL meeting request may be granted if: A request has not already been submitted for the same CRL, the proposed questions seek clarification on a deficiency (which can include, "for example, requests for clarification on requirements to address a deficiency (i.e., ‘Can the Agency clarify how the suggested limit of 1.1% for Impurity L was calculated by the Agency?')) and a complete meeting package is submitted.
And in terms of disputing the meeting minutes, the draft notes that if an ANDA applicant needs to discuss additional issues not addressed at the post-CRL meeting, the ANDA applicant should contact the project manager assigned to the ANDA.
"FDA recommends that the ANDA applicant submit its concerns about the meeting minutes in writing to FDA within 10 calendar days of receipt of the meeting minutes," the draft adds.
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA: Draft Guidance for Industry