FDA commissioner Robert Califf and chief information officer Vid Desai provide an overview of the agencys progress in data and technology modernizatio...
FDA says Teva is recalling one lot of its leukemia drug IDArubicin hydrochloride injection due to the presence of particulate matter found in one vial...
Federal Register notice: FDA extends the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to ...
FDA says it is recommending thyroid monitoring for children age 3 and younger who receive iodinated contrast media for imaging studies.
The Justice Department says a Pennsylvania man pleaded guilty to healthcare fraud and violating the Anti-Kickback Statute in a compounded medication s...
CDRH director Jeff Shuren testifies on Capitol Hill that despite the Covid-19 strain on resources, the medical device user fee programs track record c...
FDA clears a Sky Medical Technology 510(k) for its new (W3) geko device for increasing microcirculatory blood flow in lower limb soft tissue of patien...
FDA says sotrovimab is no longer authorized in three additional HHS regions where the proportion of Covid-19 omicron BA.2 variant cases is above 50% b...