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  1. Generic Drug User Fee Amendments

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

September 29, 2023 - Beginning October 2, 2023, the FDA Generic Drug Program will expand in-person face-to-face (FTF) meetings with industry.

A major theme of the GDUFA III Commitment Letter is to maximize the efficiency and utility of each assessment cycle to facilitate timely access to quality, affordable, safe, and effective generic medicines for the American public. GDUFA III includes more opportunities for applicants to engage in meetings with FDA to help facilitate development of these products and  assessment of their applications.

In March 2023, FDA resumed in-person FTF meetings with industry as a phased-in approach and only included an in-person FTF meeting option for the pre-ANDA product development and pre-submission meetings. To continue our efforts to support this major theme of GDUFA III, FDA is amending the approach to ANDA meetings in the following ways:

  1. In addition to pre-ANDA product development and pre-submission meetings, FDA will expand the offer for an in-person FTF meeting format to:
    • pre-submission product-specific guidance (PSG) meetings
    • post-submission PSG meetings
    • enhanced mid-cycle review meetings
    • post-Complete response letter (CRL) scientific meetings
       
  2. FDA will offer a videoconference format for:
    • PSG teleconferences (t-cons)
    • mid-cycle review meetings
    • post-CRL clarification t-cons

The availability of in-person FTF meetings may be limited by facility capacity and logistical considerations. Meetings that otherwise are granted but that cannot be offered 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 October 2, 2023.

In-person FTF meetings with applicants and prospective applicants  will continue to be hybrid, with small delegations from FDA in the meeting room. Other FDA staff and other applicant participants video conference into the room. FDA staff with a primary speaking role will be prioritized for in-person attendance, while others will join virtually.

Visitors must follow the appropriate FDA campus visitor requirements.

Please reach out to druginfo@fda.hhs.gov with any questions related to ANDA program industry meetings.

Information on FTF meetings for the PDUFA, BsUFA, and OMUFA programs can be found here.

March 27, 2023 - Beginning March 27,2023, 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 27, 2023.

In-person FTF meetings will be hybrid with small delegations from FDA in the meeting room—with industry members, other FDA staff, and industry video conferenced into the room. FDA will focus on having only core participants with a primary speaking role in-person while others will join virtually.

Visitors must follow the appropriate FDA campus visitor requirements.

In addition to the in-person FTF meeting format and the videoconference format, the other format options available under the GDUFA III commitment letter for meetings are teleconferences and written responses. Not all formats are available for each meeting type; for example, some meetings are only available as a teleconference. Although FDA may use the same platform (e.g., Zoom) to conduct teleconferences and videoconferences, teleconferences are not the same as or interchangeable with videoconferences. If a meeting is granted as a teleconference, it will be voice only with no projection of presentations or use of video/camera. Applicants should consider the different meeting format options available for the type of meeting they are requesting and ask for the format that suits their needs. For example, the videoconference format is typically more effective for a scientific discussion than the teleconference format.

ANDA applicants should also note that the terminology used to describe different meeting types under GDUFA varies slightly from the terminology used under PDUFA and BsUFA. While the PDUFA VII and BsUFA III commitment letters note that a FTF meeting “includes both in-person meetings and virtual meetings on IT platforms that allow for both audio and visual communication,” under the GDUFA program the term “face-to-face meeting” is used to refer to an in-person FTF meeting as described above, while “videoconference” is used to refer to a meeting in which the attendees participate from various remote locations via a video and audio connection (for more information, see FDA’s guidance for industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA [Oct. 2022]). Thus, if a generic applicant wants a videoconference meeting, they should specify that rather than asking for a FTF meeting.

As a reminder, a summary of ANDA program meetings can be found here.

Please reach out to druginfo@fda.hhs.gov with any questions related to ANDA program industry meetings.

Information on FTF meetings for the PDUFA, BsUFA, and OMUFA programs can be found here.

 
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