Complimentary Market Pathways Article Trio: Jeff Shuren & the Future of the FDA

Jeff Shuren has some big plans for FDA’s device center, but to make it happen he says it is crucial that his team has more flexibility. He wants “regulatory Legos” at the center’s disposal that it can mix and match to best meet the needs of next-gen healthcare, he explained to Market Pathways in an interview. But his favored ideas are getting under-the-radar pushback that could presage complications when FDA seeks new device authorities in conjunction with the next user-fee reauthorization—a process that will get off the ground later this year but not complete until 2022, when the White House and Senate could be in new hands.

Market Pathways is following this dynamic closely in interviews with Shuren, conference coverage, and keeping close tabs on the presidential race and Capitol Hill. We hope you find the below complimentary articles valuable to your long-term and day-to-day regulatory strategy. Click here to explore our other regulatory coverage. - David Filmore, Executive Editor, MedTech Strategist Market Pathways