Science Board Presentation

10/29/02


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Table of Contents

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Science Board Presentation

The Office of Women’s Health serves as a champion for women’s health inside and outside the agency.

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Issues for the Board

Current Pregnancy Section of Label (21 CFR 201.57)

“Pregnancy Categories”

Limitations of Existing Pregnancy Section

Changes are coming….

Revise the Regulations

Improving Label Content

Ethical Issues

Subpart A: Basic Protections

Subpart B: Special Protections for Pregnant Women and Human Fetuses

Physiological Changes in Pregnancy

FDA/DHHS/CoE Research Project

PK/PD of Antihypertensive Medications used in Pregnancy

CDER/OWH Counterterrorism Initiative Dosing and Safety in Special Populations

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Fetal Safety Studies

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University of Washington PK of amoxicillin in pregnant women Drug is renally excreted dose adjustment likely University of Wisconsin Formation of the CoE Research Consortium Proposed to study 3 drugs (ciprofloxacin, azithromycin, gentamicin) in pregnant, and lactating, patients needing medication for other infections

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Summary

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Author: margaret ann miller