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.
FDA-EMA Parallel Scientific Advice Program For Complex Generics Could Add Health Canada
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 development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
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