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Negócios · 03/08/20041 min de leitura
Draft Guidance for Industry: Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability
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Resumo
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry ( 171) entitled "Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles." This draft guidance describes the procedures that the agency recommends for the review of requests for waiver of in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →