Regulatory Harmonization and Convergence
The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER.
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Exporting CBER-Regulated Products
The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved CBER-regulated products.
Tissue Establishment Registration
Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Also, provided information on when to register update regist
Blood Establishment Registration and Product Listing
All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65
Collaborations and Partnerships
CBER Research Collaborations and Partnerships
Vaccine Adverse Event Reporting System (VAERS) Questions and Answers
VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).
Vaccine Adverse Events
Information about the Vaccine Adverse Event Reporting System (VAERS), which is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to detect possible signals of adverse events associated with v
CYFENDUS
For use as a post-exposure prophylactic vaccine following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial regimen.
Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting
Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting
What’s New for Biologics
Latest news from the Center for Biologics Evaluation and Research
BioThrax
BioThrax is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age.
Commissioner's National Priority Voucher (CNPV) Pilot Program
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
Phase 1 Investigational New Drug (IND) Navigator
The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application.
FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development
Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.
CMC and GMP Guidances
This page lists CMC and GMP Guidance documents.
Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
Labeling for CBER-Regulated Products
Labeling for CBER-Regulated Products
Laboratory Information Bulletins
Laboratory Information Bulletins available to the public
Administrative Guidances
This page lists Administrative Guidance documents.