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USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances

USFDA finalized and released four Guidelines yesterday (05 October 2022), in accordance with the time frames set forth in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).

What is GDUFA?

Generic Drug User Fee Amendment (GDUFA): is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to the industry that is reauthorized every 5 years, and this user fee program has been reauthorized two times since GDUFA I.

Fiscal Year (FY) 2023 rates for GDUFA III fees – These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.

1. Guidance on Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

In this guidance, FDA describes an enhanced pathway for discussions between the agency and prospective applicants preparing to submit to FDA an abbreviated new drug application (ANDA) for a complex product.

Basically, this guidance outlines how to request and conduct product development meetings, pre-submission meetings, mid-cycle review meetings, and enhanced mid-cycle review meetings with FDA.

2. Guidance on Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA

As part of this guidance, FDA and abbreviated new drug application (ANDA) applicants will hold teleconferences following the completion of complete response letters (CRLs) to clarify deficiencies identified in CRLs for ANDAs submitted under section 505(j) of the (FD&C Act) (21 U.S.C. 355(j)). This guidance will facilitate well-managed post-CRL clarification teleconferences, as well as facilitate the schedule and conduct of such meetings.

3. Guidance on Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments

The purpose of this guidance is to explain how FDA will issue an information request (IR) and/or discipline review letter (DRL) as part of the FD&C Act (21 U.S.C. 355(j)) when evaluating an original abbreviated new drug application (ANDA).

4. Guidance on Competitive Generic Therapies (CGT)

This guidance outlines the process for requesting designation as a CGT and describes the criteria for designation. This guidance describes how FDA may speed up the development and review of ANDAs for CGT drugs and also explains how FDA implements the 180-day exclusivity period for first approved applicants of CGTs who submit ANDAs.

Check this LINK to know more about GDUFA III enhancements and provides transparency on the FDA's generic drug program's progress and performance.


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