FDA clears a Samsung 510(k) for the GC70 Digital Radiography (DR) system.
FDA approves Inspirion Delivery Sciences RoxyBond (oxycodone hydrochloride) tablets, indicated for managing pain severe enough to require an opioid an...
Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on Citizen Petitions and Petitions for St...
Federal Register notice: FDA seeks comments on an information collection extension on Radioactive Drug Research Committees OMB Control Number 09100053...
Bristol-Myers Squibb and Transgene enter into a clinical research collaboration to evaluate Transgenes investigational therapeutic vaccine TG4010 in c...
Three professors raise issues to be resolved before a requirement for a single IRB in multi-site studies can be implemented.
Two Venable attorneys describe opportunities for stakeholders that could be part of President Trumps executive order on reducing regulations and their...
The Tatia Oden French Memorial Foundation asks FDA to conduct a Sentinel query on misoprostol adverse events and consider action to assure patient and...