Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 14/06/20161 min di lettura
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Draft Guidance for Industry; Availability
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment." This draft guidance provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis.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).
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →