FDA guidance on formal meetings adds new categories, timelines
The US Food and Drug Administration (FDA) has issued revised draft guidance to help sponsors understand the different types of meetings they can request for questions related to their applications and describes the timelines associated with these requests.The guidance incorporates the agreements reached between FDA and industry in the Prescription Drug User Fee Act (PDUFA) VII negotiations.
The guidance, announced in the Federal Register on 21 September 2023, adds two new types of meetings, a Type D meeting for topics of narrow interest and meetings through the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) pathway for new and innovative technologies. It also now classifies video conference meetings as virtual face-to-face meetings.
The guidance was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). It does not cover abbreviated new drug applications (ANDAs), applications for biosimilar biological products, or medical device submissions.
This draft guidance replaces an earlier version issued in December 2017 (RELATED: Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance, Regulatory Focus 2 January 2018).
Meeting types
The guidance describes the different meeting categories: Type A, B, C and Type D and INTERACT meetings.
Type A meetings are for products with stalled development programs or for resolving disputes. Type B meetings include pre-investigational new drug applications (pre-IND) meetings or for certain end-of-phase I meetings (EOP).
Type C meetings are reserved for issues that do not fit in these categories and can be used to consult on the use of a biomarker as a new surrogate endpoint that has never before been used.
The revision adds a new Type D meeting and INTERACT meetings. Type D meetings are “focused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to move the program forward.” These can include follow-up questions that raise a new issue after a formal meeting. These meetings should be limited to no more than two focused topics, according to FDA. The agency must respond to requests for Type D meetings within 14 days and schedule a meeting within 50 days of the request.
INTERACT meetings are reserved for “novel products and development programs that present unique challenges in early development.” These can cover questions related to the design of IND toxicity studies and complex manufacturing technologies or processes. FDA must respond to requests for INTERACT meetings within 21 days and schedule a meeting within 75 days of the request.
The guidance also adds video conference meetings (called “virtual face-to-face”) to the three other meeting formats, joining face-to-face meetings, teleconferences and written response only (WR) where written responses are sent in lieu of virtual or face-to-face meetings.
Comments can be submitted here until 21 December 2023.
Draft guidance, Notice
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