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...
FDA issues a complete response letter for Akebias vadadustat citing a negative benefit/risk assessment and safety concerns.
FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes 6 to 4 that data from a single randomized, controlled trial and an open-labe...
Federal Register notice: FDA sends to OMB an information collection extension entitled Financial Disclosure by Clinical Investigators.
FDA releases an executive summary that provides more details on the package of legislative proposals that were included in the agencys FY 2023 budget ...
The federal Cybersecurity & Infrastructure Security Agency identifies a vulnerability in the Philips e-Alert MRI monitoring platform.