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Biznes · 7.03.20081 min czytania
Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Availability
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled "Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route." The draft guidance provides recommendations concerning development of safety profiles to support approval of reformulated drug products and products proposed for use by a route of administration for which the product was not previously approved.
Oryginalny język źródła: Federal Register — Food and Drug AdministrationOtwórz oryginalny komunikat →