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The FDA plans to make tools available to provide incentives for doctors or physician groups to collaborate on stem-cell and regenerative medicine products, eventually leading to a biologics license for each doctor or group, CBER Director Peter Marks and Commissioner Scott Gottlieb said in a New England Journal of Medicine article published Thursday. Read More
Investigations and lawsuits against opioid manufacturers and distributors continued as Sen. Claire McCaskill (D-Mo.) accused a drugmaker of blocking a Senate investigation and the city of Chicago sued three distributors. Read More
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