FDA Generics Program Resumes In-Person Meetings

The FDA announced yesterday that its generic drug program has resumed in-person, face-to-face meetings with industry, in a phased-in approach alongside videoconference meetings.

Initially, the option will only be available for pre-abbreviated new drug application (ANDA) product development meetings and pre-submission meetings, the agency said.

The availability of meetings “may be limited by facility capacity and logistical considerations,” the agency said.

The plan is to include “only core participants with a primary speaking role in-person while others will join virtually.”

Requests for in-person face-to-face meetings must be part of an initial meeting request package received on or after March 27, the agency said.