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Congressional lawmakers are championing the 21st Century Cures Act as a “watershed moment” that will go a long way toward helping patients, but some consumer advocates and academics warn the legislation contains a provision that may usher in a new era of lower approval standards.

Here’s why: The bill requires the Food and Drug Administration to develop a program for evaluating the use of so-called “real world evidence” for approving additional uses of medicines, as well as for any follow-up studies that may be required (see section 3022).

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