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What's New at CBER 06/13/2023

U.S. Food and Drug Administration sent this bulletin at 06/13/2023 04:36 PM EDT
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What's New at CBER

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The following links have been updated recently:

Posted: 06/13/2023

  • June 9, 2023 Clinical Review - AFSTYLA
  • June 9, 2023 Statistical Review - AFSTYLA
  • CBER Cures Vacancy Announcement - Physician, AD-0602-Band C, Office of Vaccines Research and Review (OVRR), Division of Vaccines and Related Product Applications (DVRPA)
  • CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Oncology Branch 2 (OB2)
  • CBER Vacancy: Principal Investigator: Molecular Biologist with Bioinformatics experience
  • BK220668 - VorFat System

Upcoming CBER Workshop/Meetings/Town Halls

June

  • Vaccines and Related Biological Products Advisory Committee Meeting June 15, 2023 Announcement
    June 15, 2023
  • Virtual Meeting: Decentralized Clinical Trials (DCT) Draft Guidance
    June 20, 2023
  • FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers
    June 20, 2023

November

  • Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards
    November 7, 2023

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