[ Price : $8.95]
FDA clears a Carestream 510(k) to allow diagnostic reading of ECG waveforms on desktop displays and mobile tablets using its Vue M...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Integrated Summary of Effectiveness.[ Price : $8.95]
Amplifying his demand for CDRH director Jeffrey Shurens resignation, 510(k) critic and morcellator activist Hooman Noorchashm comp...[ Price : $8.95]
University of Florida law professor Lars Noah says FDA is using guidance documents when it would be better to use notice-and-comme...[ Price : $8.95]
FDA grants Eli Lilly a breakthrough therapy designation for abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for pa...[ Price : $8.95]
U.S. special counsel Carolyn Lerner says HHS and FDA filed satisfactory reports in response to a whistleblowers allegations that F...[ Price : $8.95]
FDA acting commissioner Stephen M. Ostroff tells an industry conference that the agency isnt a barrier in the lack of good treatme...[ Price : $8.95]
Federal Register Notice: FDA releases a final guidance on adverse event reporting for outsourcing facilities.