federal_register: 03-9065

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
03-9065 Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for Hearing Notice The Food and Drug Administration (FDA) is amending a previous Federal Register notice to reclassify certain estrogen-androgen combination drugs as lacking substantial evidence of effectiveness for the treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogen alone. The agency is taking this action because for this indication there is not substantial evidence of the contribution of each component to the effectiveness of these combination drugs. FDA is offering an opportunity for a hearing to persons affected by this action. 2003-04-14 2003 4 https://www.federalregister.gov/documents/2003/04/14/03-9065/certain-estrogen-androgen-combination-drugs-drugs-for-human-use-drug-efficacy-study-implementation https://www.govinfo.gov/content/pkg/FR-2003-04-14/pdf/03-9065.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending a previous Federal Register notice to reclassify certain estrogen-androgen combination drugs as lacking substantial evidence of effectiveness for the treatment of moderate to severe vasomotor symptoms...

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