Association of the FDA Amendment Act with trial registration, publication, and outcome reporting

Table 1 Novel therapeutic agent indications approved by the US FDA for cardiovascular disease and diabetes between 2005 and 2014

Novel therapeutic agent indication approvals (n = 32)	Number (%)
Orphan status^a
Yes	3 (9)
No	29 (91)
FDA review pathway^a
Priority	6 (19)
Standard	26 (81)
Therapeutic area^b
Cardiovascular disease	17 (53)
Diabetes mellitus	15 (47)

FDA Food and Drug Administration
^aFDA designation
^bAs defined by the World Health Organization’s Anatomic Therapeutic Classification system (http://www.whocc.no/atc_ddd_index/), contextualized for clinical relevance

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