Two Hyman, Phelps & McNamara attorneys take issue with FDAs new approach to regulate novel robot assisted surgery devices for specific indications rat...
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel describe initiatives under the Centers technology mo...
FDA denies three petitions asking it to require manufacturers of surgical staplers and staples to provide performance data on the devices safety and e...
Teligent Pharma recalls five lots of lidocaine HCl Topical Solution 4%, 50ml in screw cap glass bottles after a stability sample was found to be out-o...
FDA accepts for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized pa...
Federal Register notice: FDA announces an 11/16 virtual public meeting entitled Enhanced Drug Distribution Security at the Package Level Under the Dru...
Sens. Grassley and Warren urge FDA to quickly issue over-the-counter hearing aid regulations to implement their bill that was approved in 2017.
CDER Office of Compliance director Don Ashley tells the Food and Drug Law Institute that his office has been targeting three drug advertising and enfo...