Today, December 18, 2017, the FDA published the draft guidance for industry entitled Information Requests and Discipline Review Letters under GDUFA and a Manual of Policies and Procedures (MAPP).
In the guidance, the agency explains how the FDA will issue and use Information Requests (IRs) and Discipline Review Letters (DRLs) during the review of an original abbreviated new drug application (ANDA) under 505(j) of the Federal Food, Drug, and Cosmetic Act, in accordance with the reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA II). The MAPP describes how the FDA’s Offices of Generic Drugs and Pharmaceutical Quality in the Center for Drug Evaluation and Research will issue IRs and DRLs for ANDAs in accordance with GDUFA II.
IRs and DRLs are part of GDUFA II and are described in Sections II.B.1, VII.K, and VII.O of the GDUFA Reauthorization Performance Goals and Program Enhancements for FY 2018-2022.
A pre-recorded webinar explaining this guidance is available on the CDER Small Business and Industry Assistance Web page: https://www.fda.gov/drugs/
developmentapprovalprocess/ smallbusinessassistance/ ucm070334.htm
To comment on the draft guidance, please visit the public docket, FDA-2017-D-6752
Direct link to the guidance: https://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM588862. pdf