Guidances

• "Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies", Final, published April 2005.
• "Guidance for Industry: Establishing Pregnancy Exposure Registries", Final, published August 2002.
• "Guidance for Industry: Clinical Lactation Studies-Study Design, Data Analysis and Recommendations for Labeling", Draft, published February 2005.
• "Guidance for Industry: Pharmacokinetics in Pregnancy - Study Design, Data Analysis, and Impact on Dosing and Labeling", Draft, published October 2004.

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