The US Food and Drug Administration (FDA) resumed in-person, face-to-face (FTF) meetings with abbreviated new drug application (ANDA) sponsors on 27 March, an FDA official confirmed during a 15 May webinar sponsored by FDA’s Small Business and Industry Assistance (SBIA) program.
Yet these meetings are reserved for pre-ANDA product development meetings and pre-submission meetings, said Lei Zhang, deputy director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD).
Other types of meetings called for under the Generic Drug User Fee Amendments (GDUFA III), such as mid-review cycle meetings and post-complete response (CRL) meetings, are not yet eligible for FTF meetings. GDUFA III was authorized by Congress on 30 September 2022, and is in effect for fiscal years 2023-2027.
Zhang noted that F2F meeting requests may be limited by facility capacity and other logistical considerations. All F2F meetings are in a hybrid format, combining a videoconference and in-person format. Meetings will be attended by “core” FDA participants, as well as industry participants. From FDA, representatives are likely to include project managers, a meeting chair and subject matter experts. Other participants are remote and attending either though video or audio conferencing.
Zhang also discussed the differences between video conferences and teleconference, and what platform is most appropriate for the subject matter under discussion. For pre-ANDA meetings, video conferences are typically more effective than teleconferences because of the scientific nature and content of the discussion.
Yet teleconferences are more appropriate for requesting clarification on certain points from FDA. Videoconferences are not an option for questions on product-specific guidances (PSG) and post CRL clarifications, which must be held in teleconference format.
Zhang added that applicants should request the desired meeting format in the meeting request submitted to FDA.
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