2/28/2023 |
February 10, 2023 Approval Letter - OBIZUR |
2/27/2023 |
February 24, 2023 Approval Letter - Non-Standardized Allergenic Extracts |
2/27/2023 |
CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer |
2/27/2023 |
CBER Vacancy: Staff Fellow/Visiting Associate – Parasitic Diseases |
2/27/2023 |
February 24, 2023 Approval Letter - Allergenic Extracts |
2/24/2023 |
February 24, 2023 Approval Letter - FLUAD QUADRIVALENT |
2/24/2023 |
September 27, 2022 Approval Letter - GLASSIA |
2/24/2023 |
Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop
Updated with Draft Agenda. |
2/24/2023 |
February 22, 2023 Approval Letter - CARVYKTI |
2/24/2023 |
Center for Biologics Evaluation and Research
Updated to include contacts for the new Office of Therapeutic Products
|
2/23/2023 |
February 22, 2023 Approval Letter - Fluzone High Dose Quadrivalent |
2/22/2023 |
February 22, 2023 Approval Letter - ALTUVIIIO |
2/22/2023 |
February 22, 2023 Approval Replacement Letter - ALTUVIIIO |
2/22/2023 |
BK220790 - Blood Bank Control System, Version 6.0 |
2/17/2023 |
Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products
Updated with transcript. |
2/17/2023 |
Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards |
2/17/2023 |
Joint US FDA – Health Canada ICH Public Meeting |
2/17/2023 |
2023 Biological License Application Approvals |
2/17/2023 |
2023 Biological Device Application Approvals |
2/17/2023 |
2023 Biological License Application Supplement Noteworthy Approvals |
2/17/2023 |
FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop |
2/16/2023 |
February 16, 2023 Approval Letter - ZOLGENSMA |
2/16/2023 |
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
2/15/2023 |
February 10, 2023 Approval Letter - IMLYGIC |
2/14/2023 |
February 13, 2023 Approval Letter - Fluzone Quadrivalent Southern Hemisphere and Fluzone High-Dose Quadrivalent Southern Hemisphere |
2/13/2023 |
Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products |
2/10/2023 |
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry |
2/9/2023 |
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act |
2/9/2023 |
eSubmitter Application History |
2/9/2023 |
Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement |
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 |