The following are internet links to the Food and Drug Administration.  The FDA web sites provide invaluable information for the pharmaceutical community.

Food and Drug Administration

1. Food and Drug Administration Home Page

Center for Drug Evaluation and Research (CDER)

1. Center for Drug Evaluation and Research Home Page
2. Code of Federal Regulation (CFR) Title 21
3. Consumer Drug Information Page
    
4. Drug Approvals for Cancer Indications
5. Drug Information
6. Drug Master Files
    
7. FDA Drug Approvals List
8. FDA Enforcement Report
9. Federal Register-FDA
10. Food, Drug and Cosmetic Act
     
11. Guidance Documents
     
12. Human Drug Current Good Manufacturing Practice Notes
     
13. IND Form Help: Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
     
14. New and Generic Drug Approvals Listing
15. New Drug Approval Reports
     
16. Office of Drug Evaluation IV: Pre-IND Consultation Program
17. Over-the-Counter Drug Page
     
18. Pediatric Medicine Page
     
19. Regulatory  Guidance
20. Required Specifications for FDA’s IND, NDA, ANDA, Drug Master File Binders
     
21. Warning letters and Notice of Violation Letters

Center for Biologics Evaluation and Research (CBER)

1. Center for Biologics Evaluation and Research Home Page
2. Guidelines / Guidances
3. Investigational New Drug Application
4. Organizational Information Overview (requires Adobe Acrobat)