NEJM Takes Aim At Expensive Accelerated Approval Drugs Amid Congressional Drug Pricing Debate
Authors propose imposing penalties on drugmakers who don't start confirmatory trials shortly after accelerated approval and additional discounts for public payers; proposals could pick up steam among congressional democrats amid their renewed call for lower drug prices.
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Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
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Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.