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.
Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Humanitarian Use Devices 21 CFR Part 814....
FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies.
FDA commissioner Robert Califf lays out a six-step plan to better leverage health technology, data, and capabilities to improve healthcare outcomes an...
FDA associate commissioner for regulatory affairs Judith McMeekin shares ORAs experience during the pandemic about relying on inspection reports under...
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...