Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019

Автор: U.S. Food and Drug Administration

Загружено: 2020-03-27

Просмотров: 2378

Описание:

Callie Cappel-Lynch from CDER’s Office of New Drugs discusses processes, requirements, and best practices for PDUFA meetings. She reviews special programs that may affect the review process or timelines for an application and best practices for communications with FDA.

Learn more at https://www.fda.gov/drugs/cder-small-...

_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: / cder-small-business-and-industry-assistance
Twitter: / fda_drug_info
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...

Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019

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