Zdrowie i gospodarka · 20.12.2004
Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information." The draft guidance is intended to assist applicants with the submission of abbreviated new drug applications (ANDAs) when a drug substance exists in polymorphic forms.