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The FDA Breakthrough-Drug Designation — Four Years of Experience

2018; Massachusetts Medical Society; Volume: 378; Issue: 15 Linguagem: Inglês

10.1056/nejmhpr1713338

1533-4406

Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim,

CAR-T cell therapy research

In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of medications with potential to provide substantial improvement over existing treatments. The authors review the first 4 years of experience with this program.