Three researchers say that between 2011 and 2015, FDA approved new drugs more quickly than the European Medicines Agency.
Emergo reports that FDA 510(k) clearances were at a four-year low in 2016, as the number of applications from U.S. firms declined.
FDA commissioner-nominee Scott Gottlieb says his highest immediate priority will be to assess whether the agency has adequate authorities and resource...
FDA clears a Bausch + Lomb 510(k) for the Stellaris Elite Vision Enhancement System, the companys next generation phacoemulsification cataract platfor...
A Wall Street Journal opinion piece dismisses Democrat lawmakers criticisms of FDA commissioner-nominee Scott Gottliebs close ties to industry, and ca...
FDA authorizes 23andMe to market genetic health risk tests that can indicate a genetic predisposition to any of 10 diseases or conditions.
PhRMA launches a campaign to educate consumers about drug rebates not passed on to them by health insurers.
Two Sheppard Mullin attorneys say that mHealth app developers need to be aware that they must meet sometimes conflicting state and federal requirement...