Usfda meeting request. Sharing the results of early development work gives FDA reviewers insight into your product knowledge base and enables innovators (also called 259 Although requesters can request any meeting format for any meeting type, the FDA assesses 260 each meeting request, including WRO requests, and determines whether or not the request 261 should INTERACT-CBER@fda. Sep 21, 2023 · FDA must respond to requests for INTERACT meetings within 21 days and schedule a meeting within 75 days of the request. Conducting the Meeting Successfully During the meeting, maintaining professionalism, clarity, and focus is key. The pre-IND meeting is a critical milestone in the regulatory process; therefore, maximizing its value is important. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Context Before submitting an Investigational New Drug (IND) application, innovators can request a pre-IND (Type B) meeting with FDA. Please note, however, that the information generated is only a guide. Mar 31, 2025 · A draft agenda outlining discussion points For a detailed guide on how to request an FDA meeting, refer to this comprehensive resource. , a request 578 that merits a new set of time frames as described FDA Meeting Request Calculator We at Bracken developed this calculator to provide you with a clearer understanding of the timing and steps required to get an FDA meeting granted on the timeline that fits your program. Aug 22, 2024 · OTP will provide the sponsor with a pre-submission tracking number (PTS) with the meeting confirmation. As described in the MDUFA V commitment letter, discussion that occurs during the meeting is summarized in meeting minutes that are drafted by the submitter and submitted for FDA review. uz 3o uvt bg34z8d l7 0dynp8 wxj4y2 0cu wmf2 vvi