Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry | Guideline Explorer

Description

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 This guidance finalizes the draft guidance for industry of the same title issued on February 21, 2023.

Scope & Applicability

Product Classes

2

Generic Drugs

topic of the guidance document

RLD

Reference Listed Drug used as the basis for an ANDA submission.

Stakeholders

10

ANDA applicant

Entity that has submitted an ANDA to the FDA; Entity requesting meetings with FDA; Entity seeking a post-submission meeting; party responsible for reviewing minutes and notifying FDA of disagreements

senior management

involved in considering applicant concerns if present at the meeting

division director

Recipient of disagreement letters if no application exists

FDA POC

point of contact who conveys decisions to the applicant

POC

FDA Point of Contact for meeting coordination.

applicant

entity submitting marketing applications

prospective ANDA applicant

Entity preparing to submit an ANDA; Entity seeking a pre-submission meeting

study sponsor

Entity responsible for the study protocol

U.S. agent

Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners

contract research organization

Entity that may sign the BE study protocol

Regulatory Context

Attributes

1

GDUFA III performance goals

Timelines for FDA responses and meeting dates; Time frames and metrics for FDA meeting responses

Related CFR Sections (3)

21CFR320.24§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
(a) Bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods. FDA may require in vivo or in vitro testing, or both, to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products. Information on bioequivRead full regulation →
21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →