FDA reminds medical device makers about the beginning of National Cybersecurity Awareness Month and to remain constantly vigilant about potential vuln...
FDA makes available a guidance on Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Admi...
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Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommenda...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...