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WHAT'S NEW TODAY
The following links have been updated recently:
Posted: 03/17/2023
* March 16, 2023 Approval Letter - JYNNEOS
* February 21, 2023 Summary Basis for Regulatory Action - ALTUVIIIO
UPCOMING CBER WORKSHOPS/MEETINGS/TOWN HALLS
March
* Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop
March 30, 2023
April
* Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for
Harmonisation (ICH) E2B(R3) Standards
April 4, 2023 - November 7, 2023
* Clinical Trials: The Patient Experience
APRIL 13, 2023
* OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023
April 25, 2023
* Blood Products Advisory Committee April 26, 2023 Meeting Announcement
April 26, 2023
* Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
April 27, 2023
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