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FDA publishes an updated draft guidance on aspects of medical device cybersecurity.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...
Federal Register notice: FDA makes available a final guidance on clinical development recommendations for hepatitis B virus infection drug products.