Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application

Image of SBIA Webinar 2016

 

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On 10/13/2017, the FDA issued the Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application.

The draft guidance for industry “Determining Whether to Submit an ANDA or 505(b)(2) Application” serves as a foundational guidance to assist in determining which one of the abbreviated approval pathways under the FD&C Act is appropriate for the submission of a marketing application.  The guidance is intended for those potential drug product developers not familiar with the abbreviated approval pathways in 505(j) and 505(b)(2).

FDA is issuing this webinar as a companion to the above guidance.

Featured Speaker:
Elizabeth Giaquinto Friedman, JD, LLM
Regulatory Counsel
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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