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Mark E. Brager
July 20, 2015

AdvaMed Commends Senate Combination Products Bill

WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement after introduction in the Senate of legislation (S. 1767) to improve the efficiency of FDA’s review process for combination products:

“Combination products – whether device/drug, device/biologic or drug/biologic – represent some of the most innovative treatment options for American patients. Unfortunately, FDA’s process for determining which of its centers has primary responsibility for reviewing these products, as well as the actual review itself, often lacks predictability and efficiency, delaying patient access to these cutting-edge advancements.

“AdvaMed commends Sens. Johnny Isakson (R-Ga.), Robert Casey (D-Pa.) and Pat Roberts (R-Kan.) for introducing legislation that seeks to address this complex issue.

“We look forward to working with Congress, FDA and other key stakeholders to move this legislation forward.”

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