Pharmaceutical Policy
Documents
Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing
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- Medical necessity of estratest
- Availability of estrogen/androgen therapy
- Libido and sexual dysfunction
Reference List re: Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing
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Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661
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Citizen Petition from Solvay Pharmaceuticals
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Acknowledgement Letter from FDA DMB to Solvay Pharmaceuticals
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Answer Letter from FDA CDER to University of Massachusetts Dept of Obstetrics and Gynecology
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Answer Letter from FDA CDER to Morris Notelovitz M.D., Ph.D.
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Answer Letter from FDA CDER to Health Decisions, Inc.
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Answer Letter from FDA CDER to Massachusetts General Hospital - Vincent Memorial Hospital
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Answer Letter from FDA CDER to American Board of Obstetrics & Gynecology
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Answer Letter from FDA CDER to Prime Plus, Inc.
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Answer Letter from FDA CDER to Harvard Medical School
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