2018
Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
Puthumana J, Wallach JD, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation. JAMA 2018, 320: 301-303. PMID: 30027239, PMCID: PMC6583484, DOI: 10.1001/jama.2018.7619.Peer-Reviewed Original Research
2017
High Costs of FDA Approval for Formerly Unapproved Marketed Drugs
Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA 2017, 318: 2181-2182. PMID: 29131905, DOI: 10.1001/jama.2017.16481.Commentaries, Editorials and Letters