US FDA

Update on In-Person, Face-to-Face ANDA Program Meetings

US FDA sent this email to their subscribers on March 27, 2023.


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Receive this email as a forward? Banner FDA | CDER | SMALL BUSINESS AND INDUSTRY ASSISTANCE INDUSTRY NEWS . UPDATE ON IN-PERSON, FACE-TO-FACE ANDA PROGRAM MEETINGS Beginning March 27th, the FDA Generic Drug Program will resume in-person, face-to-face (FTF) meetings with industry in a phased-in approach in addition to meetings by videoconference. Initially, the in-person FTF meeting option will only be available for pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.  The availability of in-person FTF meetings may be limited by facility capacity and logistical considerations. Pre-ANDA product development or pre-submission meetings that otherwise are granted but that cannot be accommodated in an in-person FTF format will be conducted via videoconference.  Requests for an in-person FTF meeting must be part of the initial meeting request package received on or after March 27th. In-person FTF meetings will be hybrid with small delegations from FDA in the meeting room with industry members and with other staff from FDA and industry video conferenced into the room. FDA will focus on having only core participants with a primary speaking role in-person while others join virtually. Visit the In-Person Face-to-Face ANDA Meetings webpage for the full update. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. * * Register for Upcoming Training * View 2023 Recordings on YouTube * Follow on LinkedIn * Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at [email protected] or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |    |  Help ---------------------------------------------------------------------------------------------------------------------------------- This email was sent to using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA GovDelivery logo gOVDELlVERY
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