From: Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Novel therapeutic agent indication approvals (n = 32) | Number (%) |
---|---|
Orphan statusa | |
Yes | 3 (9) |
No | 29 (91) |
FDA review pathwaya | |
Priority | 6 (19) |
Standard | 26 (81) |
Therapeutic areab | |
Cardiovascular disease | 17 (53) |
Diabetes mellitus | 15 (47) |