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Geschäft · 31.1.20031 Min. Lesezeit
Draft Guidance for Industry on Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Recommendations for Clinical Evaluation; Availability
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Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommendations for Clinical Evaluation." The agency is revising its guidance for industry entitled "Guidance for Clinical Evaluation of Combination Estrogen/Progestin- Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women," which was issued in March 1995 (the 1995 guidance). Once finalized, this guidance will replace the 1995 guidance.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →