3/08/2023 |
February 27, 2023 Clinical Review Memo - VARIVAX |
3/08/2023 |
Statistical Review - VARIVAX |
3/08/2023 |
February 27, 2023 Clinical Review Memo - Measles, Mumps, and Rubella Virus Vaccine Live |
3/08/2023 |
Statistical Review - Measles, Mumps, and Rubella Virus Vaccine Live |
3/7/2023 |
February 27, 2023 Clinical Review - ProQuad |
3/7/2023 |
February 27, 2023 Statistical Review - ProQuad |
3/7/2023 |
CBER Vacancy: Staff Fellow/Visiting Associate - Interdisciplinary Scientist |
3/7/2023 |
OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023 |
3/6/2023 |
March 3, 2023 Approval Letter - PALFORZIA |
3/6/2023 |
March 1, 2023 Untitled Letter - Thomas Advanced Medical LLC |
3/6/2023 |
Clinical Trials: The Patient Experience |
3/3/2023 |
FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information for All Allergenic Extracts for Diagnosis of Food Allergy |
3/2/2023 |
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry |
3/2/2023 |
March 1, 2023 Approval Letter - Fluarix Quadrivalent |
3/2/2023 |
Blood Products Advisory Committee April 26, 2023 Meeting Announcement |
3/1/2023 |
February 27, 2023 Approval Letter - VARIVAX |
3/1/2023 |
February 27, 2023 Approval Letter - ProQuad |
3/1/2023 |
Complete List of Licensed Products and Establishments
Updated as of 2/28/2023 |
3/1/2023 |
Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 2/28/2023 |
3/1/2023 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 2/28/2023 |
3/1/2023 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 2/28/2023 |
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3/1/2023 |
February 27, 2023 Approval Letter - Measles, Mumps, and Rubella Virus Vaccine Live |
3/1/2023 |
February 28, 2023 Approval Letter - Flucelvax |
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
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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 |