美国FDA药物指导原则（完整版）

1. advertising

2. Bioequivalence Recommendations for Specific Products 

3. Biopharmaceutics 

4. Biosimilarity
   

5. CMC - Microbiology (Chemistry, Manufacturing, and Controls)

6. Chemistry, Manufacturing, and Controls (CMC)
   

7. HomeDrugsGuidance, Compliance & Regulatory InformationGuidances (D）
   

8. Clinical  Antimicrobial
   

9.  

10. Clinical Pharmacology
    

11. Combination Products
    

12. Concept Papers
    

13.  

14. Drug Development Tools
    

15. Drug Safety
    

16. Electronic Submissions
    

17. FDAAA (Food and Drug Administration Amendments Act)
    

18.  

19. Good Review Practices

20. Industry Letters
    

21. International Conference on Harmonisation - Efficacy
    

22. International Conference on Harmonisation - Joint SafetyEfficacy
    

23. International Conference on Harmonisation - Quality
    

24. International Conference on Harmonisation - Safety
    

25. Investigational New Drug Applications
    

26.  

27. Microbiology

28. Modernization Act
    

29. Over-the-Counter
    

30. Pharm TOX
    

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美国FDA药物指导原则（完整版）

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