Study Data Standards Update for FDA CBER

FDA’s Center for Biologics Evaluation and Research (CBER)  will host a free virtual format workshop on 5 October 2022 entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission.

CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) , which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog.

FDA will discuss the brief background of the new requirement and how SEND will aid CBER reviewers. The webinar will also address common issues in submission data.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on clinical and non-clinical data submissions for BLAs/NDAs/ANDAs/INDs to CBER
• Consultants focused on clinical and non-clinical data submission
• Healthcare professionals specializing in clinical and non-clinical data
• Foreign regulators

FDA RESOURCES

• Federal Register Notice regarding SEND for CBER
• FDA Data Standards Catalog
• Study Data Technical Conformance Guide
• FDA Study Data Standards Resources
• Email: cber-edata@fda.hhs.gov

Please visit FDA’s Study Data Standards Update for CBER: Your Guide to a Successful Submission meeting webpage for more information.