Published on Human Subjects Office (https://hso.research.uiowa.edu)

VIII. Additional References

  • Code of Federal Regulations 21 CFR 50 [1] - Protection of Human Subjects
  • Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General 21 CFR 210 [2]
  • Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR 211 [3]
  • Drugs for Human Use 21 CFR 314 [4]
  • Bioavailability and Bioequivalence Requirements 21 CFR 320 [5]
  • Over-The-Counter (OTC) Human Drugs Which are Generally Recognized as Safe and Effective and Not Misbranded 21 CFR 330 [6]
  • Biologics Licensing 21 CFR 601 [7]
Source URL: https://hso.research.uiowa.edu/viii-additional-references

Links:
[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=50
[2] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210
[3] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
[4] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314
[5] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=320
[6] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=330
[7] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601