As the FDA prepares to release its proposed rule for a unique device identifier (UDI) database, devicemakers are off the hook for UDI label scrutiny during premarket review. Continue reading »
Mar 182011
Mar 182011
The FDA plans to issue a guidance this year to help sponsors address gender disparity in clinical trial data submitted to the agency. Continue reading »
Mar 182011
The big guns in medical technology are lining up to support a bill recently introduced in Congress that would make a research-and-development tax credit a permanent part of the federal tax code: Star Tribune
(Reprint: FDANEWS vol. 8, No. 55)
Mar 082011
FDA to improve most common review path for medical devices
Goals are to foster device innovation, protect patient safety
The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.