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Presentations from the Workshop

Scientific Workshop on Labeling “Lower” Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy (VVA)

1. Slaughter, Shelley R.  Background (PDF - 104KB)

2. Van Der Vlugt, Theresa H. M.D., MPH, Estrogen History (PDF - 94KB)

3. Ashrani, Aneel A, M.D., M.S. Epidemiology of Thromboembolism in Post-menopausal Women (PDF - 2,404KB)

4. Van der Vlugt, M.D., MPH, Lower-Dose Estrogen-Alone Products and Thrombotic/Thromboembolic Events – FDA Perspective (PDF - 71KB)

5. Weissfeld, Joel L.  M.D., MPH, A Division of Epidemiology (DEPI) Review of Published Observational Research Studies That Report Cardiovascular Disease Outcomes Associated With the Use of Low-Dose Estrogen Products by Postmenopausal Women (PDF - 98KB)

6. Van der Vlugt, M.D., MPH, Lower-Dose Estrogen-Alone Products and Thrombotic/Thromboembolic Events Drug Utilization Data (PDF - 150KB)

7. Lee, LaiMing, Ph.D.  Pharmacokinetics and Systemic Estrogen Exposure with VVA Products (PDF - 322KB)

8. Shon, Jihong Potential Utility of Hemostatic Pharmacodynamic Markers for Monitoring Thrombotic/Thromboembolic Risks of Estrogen-Alone Therapy (PDF -714KB)

9. Per Morten Sandset, University of Oslo.  Estrogen Therapy and Mechanism of Thrombosis – Are There Useful Pharmacodynamics Markers? (PDF - 1534KB)

10. Gassman, Audrey M.D., Impact of Estrogen-Alone Boxed Warnings on Patient Behavior (PDF - 327KB) 

OPEN PUBLIC HEARING

1. Goldstein, Steven, M.D. Comments (PDF - 53KB)

2. Sebastian Mirkin, M.D., Scientific Workshop on Labeling of “Lower” Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy. (PDF - 286KB)

3. Stuenkel, Cynthia A., M.D. Scientific Workshop on Labeling “Low” Dose Estrogen-Alone Products for Symptoms of Vulvar Vaginal Atrophy (PDF - 849KB)

 

 

 

 

 

 

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