U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. Labeling for CBER-Regulated Products
  1. Development & Approval Process (CBER)

Labeling for CBER-Regulated Products

The Federal Food, Drug, and Cosmetic Act authorizes FDA to require that prescription drug labeling provides healthcare professionals and patients with adequate information to permit safe and effective use of drug products. The Public Health Service Act provides legal authority for the agency to regulate the labeling and shipment of biological products. Labeling is reviewed as part of a Biologics License Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), their respective supplements, annual reports, and promotional material. For the most current guidance, refer to Search for FDA Guidance Documents.

This website does not include labeling resources for Medical Devices.

Prescribing Information

Structured Product Labeling (SPL)

Patient Labeling

Package and Carton/Container Labeling

Promotional Materials

ANDA Labeling Resources

Additional Resources

Sub-Topic Paragraphs

Follow CBER

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

Subscribe for CBER Updates

Get e-mail updates on What’s New at CBER!

Back to Top