Pharmaceutical and Medical Device Regulation
- Comprehensive List of Current FDA Guidance Documents
- Electronic Orange Book of Approved Drug Products with Therapeutic Equivalents
- Laws Enforced by the U.S. Food and Drug Administration
- Medical Device Advice
- Biologics Compliance and Regulatory Information
Agricultural Biotechnology Regulation
- Genetically Engineered Animals
- Animal and Plant Health Inspection Service (USDA-APHIS)
- Biotechnology Regulatory Services (USDA-BRS)
- U.S. Regulatory Agencies Unified Biotechnology Website
The North Carolina Biotechnology Center Library collection also includes a number of books related to regulatory issues. Here is a sampling of recent book titles available for use in the library, contact a librarian for more details.
- New Drug Development: A Regulatory Overview, 8th edition (2008)
- FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics, 2nd edition (2008)
- Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (2008)
- Safety Evaluation in the Development of Medical Devices and Combination Products (2008)