The Cures Act amended the Public Health Service Act to require, with limited exceptions, a single IRB of record for federally funded cooperative research, harmonizing with the 2018 Common Rule revisions. It also accelerated FDA's adoption of real-world evidence and patient-experience data in regulatory decisions.
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Glossary Term
21st Century Cures Act
Regulatory
Also known as: Cures Act, 21st Century Cures
2016 U.S. law that, among many other provisions, authorized single-IRB review for cooperative research and expanded the use of real-world evidence.
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