The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation. Clinical Trials 2018, 15: 243-246. PMID: 29871507, DOI: 10.1177/1740774518770657.Commentaries, Editorials and Letters