Biznes · 26.01.20051 min czytania
Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Nonclinical Safety Evaluation of Drug Combinations."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.