Former FDA associate commissioner Peter Pitts says FDA needs a deputy commissioner for regulatory competitiveness to aggressively develop, coordinate,...
FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have ...
FDA approves Genentechs Tecentriq (atezolizumab) as an add-on treatment following surgery and platinum-based chemotherapy for adults with Stage II-III...
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...