That’s right! Get ready, get set, GO! Beginning March 27, 2023, OGD will start to accept requests for Face to Face (FTF) meetings again. However, according to the FDA announcement, FTF meetings will be limited to “pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.” Access may be limited to Agency resources and only prime FDA attendees that will have a speaking role will attend. Others may be available by video conference.
Requests for a FTF meeting must be accompanied by the full meeting package, so get your ducks in a row if you wish to be accepted for one of these meetings. Further information can be found on the FDA Visit the In-Person Face-to-Face ANDA Meetings webpage for the full update here.