The US Food and Drug Administration (FDA) on Monday finalized guidance on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.
The 8-page guidance, first drafted in October 2017
, offers details for companies on what a post-CRL meeting request should include, how the requests will be assessed, the procedures for conducting teleconferences, the documentation of meetings and the resolution of disputes about meeting minutes.
In terms of changes between the draft and final version, FDA said it revised the guidance to provide clarifying information on the process for submitting post-CRL meeting requests and the criteria for granting post-CRL meeting requests.
“Changes from the draft guidance include information on the process for an abbreviated new drug application (ANDA) applicant to change the list of meeting participants and clarification on when a post-CRL meeting request may be denied,” FDA said in the Federal Register
In terms of when a post-CRL meeting request may be denied, FDA notes that if questions proposed by the applicant are not clarifying questions, the meeting can be denied. Such questions can be related to facility-related issues, requests for agency input on study or formulation design, requests for amendment reclassification, disputes regarding the relevance of a deficiency, disputes regarding the determined scale-up and postapproval changes and disputes regarding guidance documents.
Additional examples include if the proposed questions are outside the scope of the deficiencies identified in the CRL or the proposed questions require additional FDA assessment of data to develop a response.
In terms of meeting participants, the guidance notes that the applicant should notify their point of contact immediately if the list of meeting participants from the applicant’s organization and consultants changes.
“In this situation, FDA may reschedule the meeting if the revised list of meeting participants requires additional FDA personnel. In the event this meeting is ultimately scheduled outside of the 30-day window, FDA will consider its GDUFA II goal of conducting the meeting within 30 days of receipt of a written request met,” the guidance says.
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry