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Negocios · 14/6/20161 min de lectura
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry; Availability
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Resumen
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment." This draft guidance provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. This guidance also discusses the nonclinical development of biopharmaceuticals (e.g., recombinant proteins and monoclonal antibodies).
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →