We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
FDA Commissioner Scott Gottlieb called the drug contracting system “rigged” in remarks Wednesday at the America’s Health Insurance Plans National Health Policy Conference in Washington, D.C. Read More
CBER’s advertising and promotional labeling branch sent an untitled letter to a drugmaker in Pennsylvania saying the company overpromised the impact of its hemophilia treatment. Read More
The Drug Enforcement Administration told an Ohio federal judge it would divulge nearly a decade’s worth of data on opioid sales after long resisting the disclosure, but only under a “for attorneys’ eyes only” protective order. Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
Oregon’s Senate advanced legislation that would introduce a drug cost and price transparency program, sending it to Gov. Kate Brown (D) for signature. Read More
The 1st Circuit Court of Appeals in Boston declined to take up Medicis’ appeal last month before March 12, when the case was scheduled to go to trial. Read More
Following FDA inspections and a warning letter, the Department of Justice filed a civil complaint against the outsourcing facility Cantrell Drug Company, of Little Rock, Arkansas seeking a preliminary injunction to halt manufacturing and order the company to recall and destroy all drugs compounded, held or distributed. Read More