What’s New for Biologics

Items related to biologics will be added to the top of the list as they are posted on the site.

2/6/2023	Extension of the Expiration Date for MICRhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] Lot MG21O04 from 24 months to 36 months (28 JAN 2023, to 28 JAN 2024)
2/3/2023	January 20,2023 Clinical Review Memo - ODACTRA
2/3/2023	Statistical Review - ODACTRA
2/2/2023	CBER Vacancy: Staff Fellow/Visiting Associate - Biologist
2/1/2023	Complete List of Licensed Products and Establishments
2/1/2023	Complete List of Substantially Equivalent 510(k) Device Applications
2/1/2023	Complete List of Currently Approved Premarket Approvals (PMAs)
2/1/2023	Complete List of Currently Approved NDA and ANDA Application Submissions
2/1/2023	Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products; Draft Guidance for Industry
2/1/2023	Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement
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Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry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Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format; Draft Guidance for Industry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