Face-to-Face ANDA Program Meetings

Expansion of In-Person, Face-to-Face ANDA Program Meetings 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 us to help facilitate development of these products and our 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: In addition to pre-ANDA product development and pre-submission meetings, FDA will expand the offer of 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 <a href="https://medium.com/@chinnak0890/face-to-face-anda-program-meetings-f59aa027fdcc">Visit Now</a>