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  1. 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

Biologics Monthly Reports

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Biological Approvals by Year | FDA
Application Checklist

Complete List of Licensed Products and Establishments | FDA
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Substantially Equivalent 510(k) Device Information | FDA
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Approved Blood Products | FDA
Decorative Image | Learn more about importing investigational new drugs

Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (AN…
Notify FDA of Illegitimate Products

User Fee Billable Biologic Products and Potencies Approved Under Section 351 of…
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CBER 2026 Orphan Approvals (new BLAs)

Biologics Performance Reports

Real World Evidence Tablet

Real-World Evidence Submissions to CBER
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Fast Track Designation Request Performance
Report significant losses, theft and falsified prescription drug samples to FDA

FDA Report to Congress: Least Burdensome Training Audit
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FDA Report to Congress: Least Burdensome Training Audit Addendum

CBER Reports older than 2020 are available on FDA Archive


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