An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Vaccines, Blood & Biologics

CBER Reports

CBER Reports are a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

Sub-Topic Paragraphs

Photo of Peter Marks, M.D, Ph.D.

CY 2023 Report from the Director

U.S. Capitol

FDA Report to Congress: Least Burdensome Training Audit

U.S. Capitol with keyboard graphic overlay

FDA Report to Congress: Least Burdensome Training Audit Addendum

person holding medical test tube

User Fee Billable Biologic Products and Potencies Approved Under Section 351 of…

Cropped shot of a man reading the label on a box of medicine in a pharmacy

Biologics PREA Reviews and Labeling Changes

Electronic document management system concept, searching and business managing files online document database, efficient archiving and company information datum.

PREA Non-Compliance Letters

FY 2020 Report from the Director

FY 2019 Report from the Director

FY 2018 Report from the Director

FY 2017 Report from the Director

magnifying glass beside keyboard

Real-World Evidence Submissions to CBER

Man using mouse; icon customer network connection fast speed, m-banking and omni channel

Fast Track Designation Request Performance

Collection of diverse American faces smiling

Demographic Yearly Data Summaries

Top