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Drugs & Targets

FDA proposes rule on reporting requirement under Right to Try Act

FDA has published the proposed new rule, Annual Summary Reporting Requirements under the Right to Try Act, that, when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act. jQuery(document).ready(function(){ jQuery('.people-thumb... […]
Assessing the impact of the CMS price transparency rule on patients with prostate cancer
Trials & Tribulations

Assessing the impact of the CMS price transparency rule on patients with prostate cancer

“It's the prices, stupid,” Uwe E. Reinhardt and authors famously wrote in their 2003 article describing the cause of high health care spending in the United States.1 Since then, multiple large analyses have confirmed that the prices of labor and goods, including pharmaceuticals and administrative costs, more so than differences in utilization, are the primary drivers of high health care spending.2,3