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