Healthcare Economist November 2, 2022
As part of The 21st Century Cures Act, FDA is required to consider additional mechanisms to expedite access to new drugs, including those currently under investigation. In fact, the 21st Century Cure Act mandates that pharmaceutical manufacturers have to post their policies on expanded access (a.k.a. “compassionate use”) for investigational drugs by: (1) the first initiation of a Phase 2 or Phase 3 study or (2) within 15 days after the drug receives a fast track, breakthrough, or regenerative advanced therapy designation.
What is expanded access? An FDA guidance document published this month defines it as follows:
Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s...
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