The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements
Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements. Clinical Trials 2018, 15: 219-229. PMID: 29871509, DOI: 10.1177/1740774518770648.Commentaries, Editorials and Letters