Table 1.

Product characteristics for cohort (2014–2016) of marketing applications reviewed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)

Characteristic	Applications (N / %) N = 107
Product type
New chemical entity	76 (71)
Therapeutic biologic	31 (29)
Therapeutic area
Oncology	27 (25)
Infectious diseases	18 (17)
Metabolic diseases	13 (12)
Neurology/psychiatry	10 (9)
Hematology	8 (7)
Cardiovascular diseases	7 (6)
Gastroenterology/hepatology	6 (6)
Pulmonology/allergy	6 (6)
Medical imaging/radiation injury	5 (5)
Rheumatology/immunology	4 (4)
Reproductive medicine	2 (2)
Dermatology	1 (1)