CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites 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On 10/13/2017, the FDA issued the Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.
The draft guidance is intended to assist applicants in generating and submitting a request for a post-Complete Response Letter (CRL) meeting to FDA as contemplated in the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II). This draft guidance clarifies the criteria for granting post-complete response letter (CRL) meeting requests (MRs) and the scope of discussions for granted meetings. Further, it is intended to provide procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the timeframes, or performance goals, set forth in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).
FDA is issuing this webinar as a companion to the above guidance.
Tamara R. Coley, JD, MPH
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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