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
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