FDA CBER

The Center for Biologics Evaluation and Research (CBER) is the branch of the U.S. Food and Drug Administration (FDA) responsible for ensuring the safety, efficacy, and quality of biologics, including vaccines. CBER regulates vaccines under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

Organizational Structure

CBER is led by the Director and comprises several offices responsible for different aspects of biologic regulation:

• Office of Vaccines Research and Review: Reviews vaccine clinical trials, manufacturing, and labeling
• Office of Biostatistics and Epidemiology: Analyzes clinical trial data and post-market safety data
• Office of Compliance: Ensures manufacturers meet regulatory standards
• Office of Cellular, Tissue, and Gene Therapies: Regulates advanced therapies
• Office of Technology and Innovation: Supports innovation in biologic development

The Vaccine Review Process

When a vaccine manufacturer seeks approval, CBER conducts a comprehensive review:

1. Pre-IND meetings: Regulatory guidance before clinical trials begin
2. IND (Investigational New Drug) review: Oversight of clinical trial phases
3. BLA (Biologics License Application) review: Comprehensive evaluation of all data
4. Facility inspections: Manufacturing plant verification
5. Labeling review: Package insert and patient information
6. Approval decision: License granted if benefits outweigh risks

Approval vs. Authorization

Comparison: BLA (Full Approval) vs. EUA (Emergency Use Authorization)

Why the Distinction Matters to the Public

The distinction between approval and authorization became a major source of public debate during COVID-19 vaccination. Some viewed EUA products as having a different evidentiary foundation than traditionally licensed vaccines, while others argued the emergency context justified an expedited regulatory review.

The evidentiary threshold for EUA differs from a BLA, but it is not absent. An EUA still requires clinical trial data demonstrating safety and efficacy. The difference is primarily in the volume of long-term follow-up data available at the time of authorization and the condensed duration of the review process. A product authorized under EUA meets the emergency evidentiary criteria for its intended use, while a licensed product meets the statutory requirements for BLA licensure.

COVID-19 vaccines initially authorized under EUA subsequently received full BLA approval as longer-term data accumulated. For example, the Pfizer-BioNTech vaccine received BLA approval in August 2021, followed by Moderna in January 2022.

For information on how the authorization pathway affects liability protections, see PREP Act & Liability.

The Role of Advisory Committees

CBER often convenes advisory committees to provide independent expert advice:

• Vaccines and Related Biological Products Advisory Committee (VRBPAC): Primary committee for vaccine review
• Committee reviews data and votes on regulatory questions
• Recommendations are advisory; final decision rests with FDA
• Meetings are public and webcast for transparency

Enforcement Authority

CBER has broad authority to enforce regulatory standards:

• License suspension or revocation: Can halt vaccine distribution
• Warning letters: Formal communication requiring corrective action
• Product recalls: Can require removal of unsafe products
• Civil and criminal penalties: For regulatory violations

Sources & Citations

• FDA: About CBER
• FDA: Vaccine Licensing Process