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İş dünyası · 26.01.20051 dk okuma
Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability
Yerel otomatik çeviri · Kaynağın orijinal dili
Özet
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Nonclinical Safety Evaluation of Drug Combinations." The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.
Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →