AAM Welcomes Passage Of CREATES Act
Legislation Allows Generics Firms To Sue Over Access To Samples
Industry has welcomed the passage of the CREATES Act in the US, which is aimed at curbing originator attempts to deny access to samples by abusing FDA safety programs.
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Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.