Drug and Device Resources

The information resources compiled at the various links below are available for use by all investigators and project teams at no cost. Through these documents, the Research Navigators can provide answers to general regulatory questions as well as access to a list of Frequently Asked Questions, templates, and other guidance documents. The list of informational resources will continue to grow as the DDRS develops.

**EFFECTIVE IMMEDIATELY**
CBER’S new mailing address:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
W071, G112
Silver Spring, MD 20993-0002

Please disregard any other address for CBER in any of our posted documents.

Click the links below for information, guidances, templates, and forms.

Disclaimer

  • Investigational Drug and Biologics Research
  • Investigational Device Research
  • Investigational Botanical Drug Products
  • Combination Products
  • Data and Safety Monitoring Plans and FDA Audits
  • Template Documents for Regulatory and Participant Binders