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FDA-EMA Parallel Scientific Advice Program For Complex Generics Could Add Health Canada

 
• By Derrick Gingery

Preliminary discussions are ongoing about adding Health Canada to the program intended to foster streamlined complex generic approval and increase access.

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The FDA-EMA parallel scientific advice program could gain more interest from industry if Health Canada joins the group. • Source: Shutterstock

The FDA-EMA parallel scientific advice (PSA) program for complex generics soon could add another regulator, which may increase the appeal of the meeting process intended to streamline patient access to the products.

Health Canada is interested in joining the group, which would make the trilateral PSA meetings (US Food and Drug Administration,...

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