FDA publishes guidance for industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

On November 24, 2020, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This guidance describes the enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an abbreviated new drug application (ANDA) for a complex generic drug product to FDA. The guidance, which was first published as a draft in October 2017:

• defines complex generic drug products for the purposes of these meetings,
• defines meeting types,
• provides related Generic Drug User Fee Amendments Reauthorization (GDUFA II) performance goals,
• offers recommendations for meeting requests, and
• provides general information on FDA’s assessment of meeting requests, rescheduling or canceling meetings, meeting package content and submission, pre-meeting communications, conduct of meetings, and meeting minutes.

FDA is issuing this guidance to assist ANDA applicants and prospective applicants in creating and submitting meeting requests, including meeting package materials, for formal meetings with FDA regarding complex generic drug products as defined in the GDUFA II Performance Goals and Program Enhancements Fiscal Years 2018-2022.

This guidance is being issued as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.

Source: USFDA