top of page

USFDA Update: In-Person, Face-to-Face ANDA Program Meetings

Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with videoconferences.


A face-to-face meeting with FDA staff at an FDA office hasn't happened in almost three years.

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.


Depending on facility capacity and logistical considerations, in-person FTF meetings may be limited, and videoconferencing may be used for pre-ANDA product development or pre-submission meetings that cannot take place face-to-face.


Visitors will follow the appropriate FDA campus visitor requirements when attending FTF meetings in-person. Small delegations from FDA will attend in-person meetings, while others will join virtually.


In addition to the in-person FTF meeting format and the videoconference format, teleconferences and written responses are also available for meetings under the GDUFA III commitment letter. The applicant should consider the different meeting formats available for the type of meeting he or she is requesting and request the format that is most convenient for them.


Requests for an in-person FTF meeting must be part of the initial meeting request package received on or after March 27, 2023


Click this LINK to know more about the Face-to-Face ANDA Program Meetings


If you are looking for more information on the Meetings, see FDA’s guidance for industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.

Comments


bottom of page