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.
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