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Jeffrey Shuren

Latest Headlines

Latest Headlines

Hamburg appoints FDA deputies; Spielberg oversees drugs

FDA Commissioner Margaret Hamburg has hired from the outside and promoted from within in naming two deputy commissioners. Stephen Spielberg becomes deputy commissioner for medical products and

Shuren talks CDRH performance, staffing in Boston

Waltham, MA--CDRH director Jeffrey Shuren was forthright in talking about some of the performance issues for which his center has been criticized. "I have issues with the number of the times we're

Hatch, FDA officials address MDMA

Washington, D.C. -- A bevy of medical device execs gathered in the nation's capital last week for the annual meeting of the Medical Device Manufacturers Association to hear hot topics affecting the

Shuren to appear before House panel this week

CDRH head Jeffrey Shuren will finally appear before the a U.S. House Oversight & Government Reform subcommittee to discuss the FDA and its medical device approval process. The panel had been

Shuren to appear on Capitol Hill to discuss FDA approvals

CDRH head Jeffrey Shuren warned Tuesday the U.S. faces a "perfect storm" of challenges that threaten its global leadership position in medical technology. A weak economy, changing science and red

FDA imposes high hurdle for Cytori breast repair device

Cytori Therapeutics may need to spend $10 million more than anticipated to get clearance for its first product because of a stricter-than-anticipated regulation. Cytori had laid out $200 million in

Live from MDMA: Shuren shows off transparency

WASHINGTON, D.C. -- Center for Devices and Radiological Health Director Jeffrey Shuren aimed to reassure attendees of the 16th Medical Device Manufacturers Association meeting Tuesday that the center

Med device leaders air complaints at FDA meeting

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, traveled to Minnesota this week to hear what medical device industry leaders have to say about the FDA's device

Should the FDA regulate medical apps?

Smart phones, iPads, iPhones--all are becoming regularly used tools among doctors. A station in Myrtle Beach, SC, for example, recently reported on Dr. Claudio Palma, who has an iPad hooked up to the