'The U.S. House of Representatives is set to vote this week on the 21st Century Cures Act, which looks to speed up FDA approval of both new drugs and devices, as well as provide a boost in funding for medical research.'
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Much of the bill focuses on the FDA, including provisions to establish an expedited review for breakthrough devices, hastening reviews of drug-device combos and increasing patient participation in drug approvals.
The bill would also require the FDA to evaluate the use of “real world” evidence to support new uses and post-approval studies for previously approved drugs, as opposed to the gold standard of randomized clinical trials.'
Has to be good news for SRX and their R&D pipeline.
The last sentence would be beneficial for new indications of SIRT.
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