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M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

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:

Guidance Document

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:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m3r2-nonclinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization

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