The FDA's Breakthrough Therapy Designation (BTD) program can reduce the time to market for critical drugs while maintaining safety standards.
The BTD program is designed to expedite the development of drugs targeting serious conditions for which there are not yet effective medical treatments.
While accelerating the time it takes to get drugs to market can save lives, it also raises questions about unintended consequences, particularly regarding the quality and safety of approved therapies.
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Social enterprises in Russia are bridging a gap between the state and the third sector.