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MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

Executive Summary

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

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US FDA Toying With Idea Of ‘Regulatory Legos’ In MDUFA V

Noting the latest round of user-fee negotiations are coming up, FDA device center head Jeff Shuren recently floated the idea of developing statutory building blocks – or what he calls ‘regulatory Legos’ – that would allow the agency to keep up with rapidly advancing medtech products. Instead of constantly asking Congress for new statutory authorities as technology advances, he said, the FDA could have broader authority to bring new products not covered under its current authority to market.

Medtech Bill Sponsor Sen. Isakson Retiring At Year’s End

Sen. Johnny Isakson, R-GA, who has sponsored and backed several key pieces of device-industry legislation over the last several years, said on 28 August that he will retire from the US Senate on 31 December 2019, due to health challenges.

Preferential Treatment: US FDA Asks Patients For Their Input

As the agency continues to incorporate more patient-preference data into its regulatory process, it is asking stakeholders on the kinds of diseases and other factors it should consider when evaluating patient-preference information. The feedback is ultimately meant to inform regulators and sponsors about what patients want as they develop products.

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