Items related to biologics will be added to the top of the list as they are posted on the site.
1/30/2023
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2023
1/27/2023
January 20, 2023 Approval Letter - ODACTRA
1/27/2023
Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry
1/25/2023
January 25, 2023 Approval Letter - DENGVAXIA
1/23/2023
CBER Vacancy: Product/Chemistry, Manufacturing and Controls (CMC) Reviewer
1/20/2023
January 9, 2023 Statistical Review - ADACEL
1/20/2023
January 9, 2023 Clinical Review - ADACEL
1/17/2023
BK220775 - Procedure Tray-Lipoaspirate fat harvest and injection kit
1/13/2023
CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older
1/13/2023
Clinical Investigator Status (Biologics)
1/13/2023
January 12, 2023 Approval Letter - FluMist
1/12/2023
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry
1/12/2023
December 16, 2022 Summary Basis for Regulatory Action - ADSTILADRIN
1/11/2023
eSubmitter Application History
1/11/2023
Tissue Reference Group - Updated
1/11/2023
FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - Updated with transcripts.
1/10/2023
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
1/10/2023
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
1/10/2023
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
1/10/2023
January 9, 2023 Approval Letter - ADACEL
1/9/2023
OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases
1/4/2023
Format and Content of a REMS Document; Guidance for Industry
1/3/2023
Complete List of Licensed Products and Establishments
1/3/2023
Complete List of Substantially Equivalent 510(k) Device Applications
1/3/2023
Complete List of Currently Approved Premarket Approvals (PMAs)
1/3/2023
Complete List of Currently Approved NDA and ANDA Application Submissions
1/3/2023
BK220788 - Aurora Xi Plasmapheresis System
12/27/2022
BK220767 - Lipocube Nano, Liopcube Hybrid I, Lipocube Hybrid II, Centrifuge Container
Content current as of:
01/30/2023