Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Amendments; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Product- Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance provides recommendations to industry on product- specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA, or an applicant that has submitted to FDA, an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, this guidance provides information on requesting and conducting PSG meetings with FDA (i.e., pre-submission PSG teleconferences, post-submission PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance provides procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter. This guidance finalizes the draft guidance for industry of the same title issued on February 21, 2023.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.