CBER Reports

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

General

CY 2024 Report from the Director

FDA Report to Congress: Least Burdensome Training Audit

FDA Report to Congress: Least Burdensome Training Audit Addendum

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

Biologics PREA Reviews and Labeling Changes

PREA Non-Compliance Letters

CBER Reports older than 2020 are available on FDA Archive

CY 2023 Report from the Director

FY 2020 Report from the Director

FY 2019 Report from the Director

FY 2018 Report from the Director

FY 2017 Report from the Director

Biologics Performance Reports

Real-World Evidence Submissions to CBER

Fast Track Designation Request Performance