“Bridging What is Known and What is Not Known” FDA Perspective and Response
Topics
FDA Drug Regulation
Requirements for Pharmaceuticals: Effectiveness
Requirements for Pharmaceuticals: Safety
Estrogen and Progestin Drugs Approved for Menopausal Conditions
Approved Indications for Menopausal Conditions
Treatment of Vasomotor Symptoms: Current Standards
Treatment of Vulvar Vaginal Atrophy
Prevention of Osteoporosis
Estrogens & Progestins, and Estrogens, Approved for Prevention of Postmenopausal Osteoporsis
FDA- approved Non-estrogens for Treatment and Prevention of Premenopausal Osteoporosis
“Pre-WHI” Safety Labeling: Prempro
Impact of WHI Results on Menopausal Drug Development
Generalizability of WHI Results: What do results with Prempro imply for other estrogen/progestin drugs
Composition
Composition of Premarin Component of Prempro
Sodium [Estrogen] Sulfate mg/.625 mg tablet
Composition: Estrogens
Composition: Progestins
Dosage
Pharmacokinetic Studies
PPT Slide
Generalizability: Dose
Risk Management Implications of WHI findings
Risk Management: Information Dissemination
Summary
Home Page: http://www.fda.gov/cder/present/index.htm
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