Biologics

Warning Letter — Genzyme Ireland Limited

Tissue & Advanced Therapies Research

Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research

Blood Research

Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases

Allergenics Research

Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024

ELEVIDYS

NUVAXOVID

510(k) Blood Establishment Computer Software - 2026

BK261333- Blood Product Questionnaire Module (v2.0.0)

Contacts in the Center for Biologics Evaluation & Research (CBER)

Pfizer-BioNTech COVID-19 Vaccine

Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing

Moderna COVID-19 Vaccine

VISTASEAL

Vaccines Licensed for Use in the United States

Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

BK251274- RegenBMC® (RegenKit®-THT®-BMC)

BK261335- LIAISON® MUREX HIV Ab/Ag HT; LIAISON®XL; LIAISON® diluteX

BK261315- ELUclear Elution Kit

Elecsys Anti-HBc II

MNEXSPIKE

Real-World Evidence

COMIRNATY

CBER Labeling Changes Related to Safety Findings that Used Real-World Evidence – FDA and Sponsor Conducted Studies

CBER Biological Product Approvals that Used Real-World Evidence

FDA Use of Real-World Evidence in Regulatory Decision-Making

CDER Postmarketing Studies that Used Real-World Evidence

Blue Horizon International, LLC - 728085 - 05/26/2026

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

Warning Letter — Blue Horizon International, LLC

International Activities

Health Fraud Scams

SEVENFACT

COAGADEX

IDELVION

CARVYKTI

Micro Typing Systems A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card

DG Gel Card 125445, 125449, 125450 - 125457

New Approach Methodologies (NAMs)

Coronavirus (COVID-19) | CBER-Regulated Biologics

BK261329- Erytra Eflexis

Adnan M. Dahdul, M.D. - 719607 - 05/15/2026

Adnan Dahdul, MD - 719607 - 03/12/2026

Individual Case Safety Reports

Warning Letter — Adnan Dahdul, MD

Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1

Blood Grouping Regents, BL 101728-34;103292; 125848-125855

Blood Grouping Reagents - ORTHO Sera, ALBAclone

Diagast Bundled BLA 125615, 125619 to 125626

Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242)

SPIKEVAX

2026 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Announcement - 06/18/2026

2026 Safety and Availability Communications

eSubmitter Application History

CSL Behring - 716297 - 05/13/2026

CSL Behring - 716297 - 09/09/2025

Roster of the Vaccines and Related Biological Products Advisory Committee

BK261326- Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400)

BK261331- ORTHO Optix™ Reader

PEDIARIX

BOOSTRIX

INFANRIX

Ongoing | Infectious Disease Accelerated Approvals Vaccines

Administrative Guidances

ENGERIX-B

Study Data Technical Conformance Guide - Technical Specifications Document

Biological Approvals by Year

Electronic Submission of Postmarket Safety Reports

Smallpox

ACAM2000

Instructions for Completing Form FDA 3500

Estar Technologies Ltd - 716831 - 04/22/2026

Warning Letter — Estar Technologies Ltd

Advertising & Promotional Labeling Questions and Answers

Postapproval Pregnancy Safety Studies