• Center for Drug Evaluation and Research Home Page

• Code of Federal Regulation (CFR) Title 21
• Consumer Drug Information Page
• Drug Approvals for Cancer Indications
• Drug Information
• Drug Master Files
• FDA Drug Approvals List
• FDA Enforcement Report
• Federal Register-FDA
• Food, Drug and Cosmetic Act
• Guidance Documents
• Human Drug Current Good Manufacturing Practice Notes
• IND Form Help: Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
• New and Generic Drug Approvals Listing
• New Drug Approval Reports
• Office of Drug Evaluation IV: Pre-IND Consultation Program
• Over-the-Counter Drug Page
• Pediatric Medicine Page
• Regulatory  Guidance
• Required Specifications for FDA’s IND, NDA, ANDA, Drug Master File Binders
• Warning letters and Notice of Violation Letters

Center for Biologics Evaluation and Research (CBER)

• Center for Biologics Evaluation and Research Home Page

• Guidelines / Guidances
• Investigational New Drug Application
• Organizational Information Overview (requires Adobe Acrobat)

Other

• Patent and Trademark Office