About FDA
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Maternal Health Team: Regulatory Information
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Guidances
Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3.1MB)
Reviewer Guidance, Final, published April 2005Establishing Pregnancy Exposure Registries (PDF - 266KB)
Guidance for Industry, Final, published April 2002Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB)
Guidance for Industry, Draft, published February 2005Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324KB)
Guidance for Industry, Draft, published October 2004
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