Answers are grounded in this paper and cite their sources.
The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.
No takes yet. Share an insight, caveat, or question.
Sherman et al. (2013) studied this question.
Synapse has enriched 10 related papers. Consider them for comparative context: