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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Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information." The draft guidance is intended to assist applicants with the submission of abbreviated new drug applications (ANDAs) when a drug substance exists in polymorphic forms.

Source: Federal Register — Food and Drug AdministrationOpen original release →