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On 11/3/2017, the FDA issued the Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.
This presentation describes the process for submitting and responding to controlled correspondence, the process for submitting and responding to requests to clarify ambiguities and reviews inquiries that are considered and those that are not considered to be controlled correspondence. The webinar is intended to serve as a companion to the above guidance. Please review the guidance in its entirety.
Lisa Bercu, 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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