Ted Cruz bill would speed FDA approval of drugs OK'd in other countries

Washington Examiner

18 July 2019 - Drugs and medical devices that have been authorised in other developed countries would face fast-track approval in the U.S. under a bill introduced Thursday by Ted Cruz.

The bill, the "RESULTS Act," would give the FDA 30 days after a company sends in an application to decide whether it wants to greenlight a drug, device, or biologic approved in another country that adequately checks for safety and effectiveness. If FDA decides to reject the application, Congress would have the power to override the decision.

"If it’s good enough for other countries, we should have access to those too," an aide to the Republican Texas senator said in an interview with the Washington Examiner.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation