The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.
These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
On December 15, 2017 the FDA issued the Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA.
This presentation describes how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the review of an original abbreviated new drug application (ANDA).
In negotiations held for the reauthorization of GDUFA I, it was agreed that FDA will (1) issue an IR to request further information or clarification that is needed or would be helpful to allow completion of a discipline review and/or (2) issue a new type of letter for ANDAs, known as a DRL, to convey preliminary thoughts on possible deficiencies found by a discipline reviewer and/or review team for its or their portion of the application under review after a discipline review.
This webinar is intended to be a supplement to the guidance and we encourage you to review the guidance in its entirety.
Philip Bonforte, JD
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707
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- FRN: FDA-2017-D-6752
- Draft Guidance for Industry on Information Requests and Discipline Review Letters Under GDUFA
- GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter)
- CDER MAPP on Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications