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Posted 08 May 2017 | By Zachary Brennan
Ahead of Wednesday’s Senate health committee vote on the five-year reauthorizations of the US Food and Drug Administration (FDA) user fee agreements, the committee has released an updated version of the legislation that includes several medical device bills discussed on the House side.
The so-called manager’s amendment of the bill features the same drug, medical device, biosimilar and generic drug user fee agreements crafted over the past two years, as well as new sections on “Pediatric drugs and devices,” “Reauthorizations and improvements related to drugs,” “Device inspection and regulatory improvements,” and additional provisions.
Under the pediatric section, the bill calls on FDA’s Center for Devices and Radiological Health (CDRH) within one year of enactment, to, among other provisions, hold a public meeting and aid device manufacturers to help in the development, approval and labeling of medical devices for children.
The bill also calls on FDA to issue guidance on the development of oncology drugs for pediatric populations.
Meanwhile, the section on reauthorizations and improvements for drugs would require FDA to issue product-specific guidance outlining how to demonstrate bioequivalence for complex non-biologic drugs, in addition to reauthorizing the orphan grants program and the critical path public-private partnerships.
Under the section on device inspections and regulatory improvements, the bill integrates the concepts of House-introduced bills on over-the-counter hearing aids, improving the existing processes and standards for domestic and foreign medical device establishment inspections, facilitating more international harmonization, ensuring device accessories are appropriately classified, and authorizing FDA, under certain conditions, to approve or clear an imaging device or an imaging device enhancement for use with a contrast agent in a new indication.
And under the additional provisions section of the bill, the Comptroller General of the US by September 2018 shall issue a report assessing the progress FDA has made on— “(1) working with other regulatory authorities of similar standing to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; (2) providing consistent parallel scientific advice to manufacturers seeking simultaneous global development and approval of new medical products, in coordination with regulatory authorities of similar standing; and (3) facilitating the use of foreign clinical trial data to minimize duplicative clinical trials.”
Tags: user fees, FDA user fees, PDUFA, MDUFA, BsUFA, GDUFA