S 5123
Breakthrough Therapies Act
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- Passed Senate
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- Became Law
Bill overview
The Breakthrough Therapies Act amends the Controlled Substances Act to streamline research involving breakthrough therapies. It establishes a faster registration process for researchers studying these drugs, particularly those used in investigational new drug applications, and allows for expedited registration without a full review if certain conditions are met. The bill also clarifies how manufacturing activities related to research on these substances are treated and updates definitions related to ‘currently accepted medical use with severe restrictions’ to include breakthrough therapies and expanded access programs. Finally, it mandates transparency regarding the criteria used to classify substances for research purposes.
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