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  1. Guidance, Compliance & Regulatory Information (Biologics)

Compliance Actions (Biologics)

CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products, including:

  • Conducting pre-license and pre-approval inspections of manufacturing facilities and products under clinical study.
  • Monitoring the safety, purity and potency of biological products through review of:
    • Biological Product Deviation Reports (BPDRs) and HCT/P Deviation Reports,
    • Investigations into transfusion and donation related fatalities and other adverse events,
    • Product recalls.
  • Monitoring reports of biological product shortages.
  • Initiating regulatory action to address non-compliance with FDA laws and regulations.
  • Monitoring of research conducted on biological products and assessing the protection of the rights, safety, and welfare of human research subjects and the quality and integrity of research data.
  • Monitoring import and export activities.
  • Reviewing product advertising and promotional labeling.

Adverse Events and Product Deviations


Product Safety & Availability


Regulatory Actions Issued by CBER

Administrative Actions Issued By CBER

Sub-Topic Paragraphs

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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002


(800) 835-4709
(240) 402-8010

For Updates on Twitter, follow @fdacber

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