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AAM Welcomes Passage Of CREATES Act

Legislation Allows Generics Firms To Sue Over Access To Samples

 
• By Dave Wallace

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.

Abuse
The CREATES Acts aims to curb originator abuse of FDA safety programs • Source: Shutterstock

Industry has welcomed the passage of the Creating and Restoring Equal Access to Equivalent Samples Act in the US. The legislation, known as the CREATES Act, allows developers of generics to sue originators when attempts to obtain samples of brands for development purposes are frustrated, particularly in the case of abuse of safety programs such as US Food and Drug Administration risk evaluation and mitigation strategies (REMS).

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