Federal Register notice: FDA classifies the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls).
FDA commissioner Scott Gottlieb says he wants more agency investigators at international mail facilities to help intercept illegal drug shipments, par...
Federal Register notice: FDA seeks comments on an information collection for Reclassification Petitions for Medical Devices 21 CFR Section 860.123 (O...
In a precedent-breaking speech, FDA commissioner Scott Gottlieb tells health insurers they need to change payment practices to help the biosimilars ma...
A Tufts Center for the Study of Drug Development survey finds that many drug trial sponsors and CROs are somewhat or completely unsatisfied with their...
Esperion reports positive top-line results from a pivotal Phase 3 study (Study 4 or 1002-048) involving its investigational cholesterol-lowering bempe...
FDA clears a Strykers Spine division 510(k) for its Tritanium TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion cage intended for use as ...
Yale University researchers say few drug DTC ads follow FDA regulation requirements and often are unreliable and misleading.