M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
This guidance was published by the U.S. Food and Drug Administration (FDA).
January 2010
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M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
January 2010 |
In this Technical Brief:
Product Type(s):
- Pharmaceuticals
Topic(s):
- Human Clinical Trials
Region(s):
- United States
Full Info:
Resource Type:
Citation:
U.S. Department of Health and Human Services, Food and Drug Administration
Authors: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Health Risks(s):
- HIV
- STI / STD
- Unintended Pregnancy
Product type(s):
- MPTs
Topic(s):
- Development
- Trials
- Regulatory
Region(s)
- United States
URL of resource: