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Pfizer Says FDA Draft Guidance Is Just Fine; Congress Should Be Patient

 
• By Sarah Karlin-Smith

In an unusual move, industry rep indicates comfort with draft guidance implementing biosimilar pathway.

Pfizer Inc.’s VP of U.S. Regulatory Strategy Brian Harvey expressed a rare sentiment Dec. 12: industry comfort with uncertainty; indicating the company was OK with FDA’s implementation of the biosimilar pathway through draft guidance and urged legislators to focus on the quality of those documents, not their “draft” status.

Harvey’s concern about legislators meddling in the Biologics Price Competition and Innovation Act was sparked by a Dec. 4 meeting...

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More from North America

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• By Sue Sutter

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