FDA posts a guidance on Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.
FDA releases a guidance on Display Devices for Diagnostic Radiology that is intended to assist industry in preparing premarket notification submission...
FDA Review posts the Federal Register notices for the week ending 9/29/2017.
FDA makes available a guidance on Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.
Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommenda...
Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agencys newly established Opioid Policy Steering Committee.
A recent corporate integrity agreement between Aegerion Pharmaceuticals and HHS Office of Inspector General provides insights into the safeguards OIG ...
FDA clears a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixation in the occipito...