FDA updates guidances to meet GDUFA III goals

Oct. 7, 2022

In a quest to meet new GDUFA III commitments, the FDA updated two generic drug guidances and issued two draft guidances.

On September 30, 2022, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2027.  The FDA has now revised guidances accordingly:

1). Competitive generic therapies: Revising the guidance that was issued in March 2020 which created a pathway by which FDA may, at the request of the applicant, designate a drug with 'inadequate generic competition' as a competitive generic therapy (CGT). The revision was issued to incorporate information on the meeting types and performance goals included in the GDUFA III commitment letter.

The guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs.

2)  Formal meetings between FDA and ANDA applicants of complex products under GDUFA Revising the guidance issued in Nov. 2020h, this guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted an ANDA for a complex product. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, mid-cycle review meetings, enhanced mid-cycle review meetings, and post-complete response letter scientific meetings with FDA.

3) Facility readiness: Goal date decisions under GDUFA (draft guidance): Previously, a GDUFA goal date was assigned without regard to facility readiness. In the GDUFA III commitment letter, FDA agreed to incorporate facility readiness into goal date assignment. The draft guidance provides information to applicants on how the agency intends to assign a goal date.

4) Review of drug master files in advance of certain ANDA submissions under GDUFA (draft guidance): Intended for holders of Type II  API drug master files (DMFs) that will be referenced in an ANDA, this guidance describes instances when an early assessment, or 'DMF prior assessment,' could be requested by a DMF holder and the circumstances under which FDA would agree to an early assessment.