VIII. Additional References
- Code of Federal Regulations 21 CFR 50 - Protection of Human Subjects
- Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General 21 CFR 210
- Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR 211
- Drugs for Human Use 21 CFR 314
- Bioavailability and Bioequivalence Requirements 21 CFR 320
- Over-The-Counter (OTC) Human Drugs Which are Generally Recognized as Safe and Effective and Not Misbranded 21 CFR 330
- Biologics Licensing 21 CFR 601
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