According to the Office of Generics Drugs (OGD) September 29, 2023 announcement (here) on October 2, 2023 OGD will expand the types of face-to-face (FTF) meeting it will entertain. That is of course, if the government does not shut down on Sunday October 1, 2023. Prior to this announcement, and after the Covid emergency was over, OGD announced on March 23, 2023, it would schedule FTF meeting only “for an in-person FTF meeting option for the pre-ANDA product development and pre-submission meetings”. This new expansion of the meeting types is consistent with the spirit of GDUFA III and OGD’s efforts to increase efficiency in both the development process and review of generic drug applications.
So beginning on October 2nd, in addition to the two meeting types mentioned above, OGD will entertain FTF meeting requests for the following types of meetings:
- pre-submission product-specific guidance (PSG) meetings
- post-submission PSG meetings
- enhanced mid-cycle review meetings
- post-Complete response letter (CRL) scientific meetings.
They will also entertain videoconference meeting requests for the following types of meetings:
- PSG teleconferences (t-cons)
- mid-cycle review meetings
- post-CRL clarification t-cons
Remember, OGD cautions that space availability may be a factor in scheduling FTF meetings, but they will also offer a videoconference should space availability becomes an issue.
OGD also notes the FTF meeting may be hybrid, with some FDA staff in the room but others participating by video feeds. OGD also reminds applicants that any FTF meeting request must be made in the original meeting package submitted on or after October 2, 2023.
This is a nice bone that OGD was able to throw industry and I am sure we will hear more about it at the AAM’s meeting in Bethesda beginning on October 2nd.
