Medtronic recalls certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error that could cause the devices to not deliver basal ...
CDERs Office of Prescription Drug Promotion issues Bausch Health Companies an untitled letter that cited the firm over its promotional communications,...
A bill introduced by Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) pressures FDA to issue its final rule within 30 days allowing over-the-co...
In a significant blow to Biogens controversial accelerated approval of Aduhelm (aducanumab), CMS says Medicare will cover traditionally, not accelerat...
FDA authorizes a two-month shelf life extension for Janssens refrigerated Covid-19 vaccine.
The Justice Department says the former CEO of Floridas Pharmatech has been indicted in connection with a 2016 inspection that found traces of B. cepac...
FDA publishes an updated draft guidance on aspects of medical device cybersecurity.
Federal Register notice: FDA makes available a draft ICH guidance entitled M7(R2)Addendum: Application of the Principles of the ICH M7 Guideline to Ca...