CBER held a discussion regarding CBER's support and requirements beginning March 15, 2023, for the Standard for Nonclinical Data Exchange (SEND) published in the Federal Register on July 14, 2020, and the inclusion of SEND for CBER in the FDA Data Standards Catalog.

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03:50 – Update on Study Data Standards for CBER: Your Guide to a Successful Submission

12:20 – Clinical data: Validation process for CBER study data standards

22:00 – Questions and answers discussion

Speaker:

Lisa Lin
Study Data Standards Manager
Data Standards Branch
Office of Regulatory Operations CBER FDA

Gabriela Lopez Mitnik
Project Manager
Data Standards Branch
Office of Regulatory Operations CBER FDA

For more information, visit: https://www.fda.gov/drugs/news-events-human-drugs/study-data-standards-update-cber-your-guide-successful-submission-10052022

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