Zdrowie i gospodarka · 09/07/2007

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