What’s Happening With the Medicare Drug-Price Negotiation Lawsuits?
Over the past year, drugmakers and lobbyists have filed 10 different lawsuits against the federal government’s efforts to lower prescription drug costs via the Medicare Drug Price Negotiation Program. It’s still early days for these cases, but so far the government has won “every substantive motion,” Zachary Baron, JD, of the O’Neill Institute for National […]
Accelerated Approval Not the Finish Line, Says FDA Commissioner
Drugmakers will no longer be able to slow-walk their accelerated approvals to full regulatory approval, said FDA Commissioner Robert Califf, MD, during the J.P. Morgan Healthcare Conference on Tuesday, while also fielding questions on gene therapies and the modernization of clinical trials, among other topics. Accelerated Approval When asked about the kind of data needed […]