Regulatory and Legal
Aug 10, 2015
Marie Thibault     Hundreds of people have sent comments to FDA petitioning against Bayer HealthCare's Essure permanent birth control system. Most...
Aug 04, 2015
Marie Thibault   Almost six months after news broke of the carbapenem-resistant enterobacteriaceae (CRE) outbreak at Los Angeles's Ronald Reagan UCLA...
Jul 31, 2015
Marie Thibault FDA has long combated stereotypes that its regulatory process is too slow, too cumbersome, and discourages medical innovation in the United...
Jul 13, 2015
Marie Thibault Public Citizen, a public advocacy group, wants to see a Sanofi surgical device taken off the market almost 20 years after it received FDA...
Jul 06, 2015
Marie Thibault The Essure permanent birth control device is set to receive more scrutiny. FDA recently announced that it will convene a September 24 meeting...
Jul 02, 2015
Marie Thibault Legislators have considered several pieces of legislation related to medical innovation this session, including the "21st Century Cures...
Jun 29, 2015
Marie Thibault   If you thought the definition of a "surgical gown" was obvious, think again. FDA has set out its policy on what is and is not a...
Jun 25, 2015
Marie Thibault As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices,...
Jun 24, 2015
Marie Thibault FDA has published draft guidance to give industry a better idea of what the agency looks at when deciding whether to approve an Investigational...
Jun 12, 2015
Marie Thibault One of the patent reform bills introduced in this Congressional session—the Innovation Act (H.R. 9) is set to advance to the House floor...