Guidance for Industry
Reproductive and
Developmental Toxicities —
Integrating Study Results to
Assess Concerns
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 2011
Pharmacology and Toxicologyfull-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079240.pdf
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