Regulatory Links
- FDA - Division of Drug Marketing, Advertising, and Communications (DDMAC)
- FDA Guidances (Drugs)
- FDA - Newly Added Guidance Documents
- FDA - Office of Compliance
- FDA - Regulatory Guidance Drug Registration and Listing
- FDA Enforcement Actions - Unapproved Drugs
- FDA - Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
- CFR - Code of Federal Regulations Title 21
- FDA: Center for Drug Evaluation and Research (CDER)
- FDA: CDER Guidance Documents
- FDA: Center for Biologics Evaluation and Research (CBER)
- FDA: CBER Guidance Documents
- FDA: Abbreviated New Drug Application (ANDA) Process for Generic Drugs
- FDA: Current Good Manufacturing Practices (cGMP) Regulations (21 CFR Parts 210 and 211)
- FDA: Drug Master Files (DMF guidance and DMF Database)
- FDA: Center for Devices and Radiological Health (CDRH)
- FDA: CDRH Regulatory and Marketing Advice for Medical Devices
- FDA Freedom of Information Index
- FDA Recalls
- FDA Inspection Guides
- U.S. Code
- CBER Guidelines
- CDER Guidelines
- CDRH Guidelines
- CDRH Documents
- CGMP
- Investigation Operations Manual
- FDA Medwatch (Medical Product Reporting Program)
- FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)
- US Drug Enforcement Administration (DEA)
- DEA - Office of Diversion Control
