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Update on In-Person, Face-to-Face ANDA Meeting

March 29, 2023

Recent update by #FDA:

#Face-to-Face Meetings are back for ANDAs:

The FDA's generic drug program will restart holding face-to-face (FTF) meetings with the industry again starting March 27 in a phased-in manner in addition to videoconferences. The option for In-person FTF will be available for Pre-ANDA product development meetings and pre-submission meetings when requested by the applicant.

Facility capacity and logistical concerns may put a cap on the number of in-person FTF meetings that can be held. If otherwise permitted but unable to be accommodated in an in-person FTF format, pre-ANDA product development or pre-submission meetings will be held through videoconference.

In-person FTF meeting requests must be included in the original meeting request package that is received on or after March 27th.

Further information can be found on the FDA Visit the In-Person Face-to-Face ANDA Meetings webpage for the full update here

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