drug approval Article 9 human 9 Food and Drug Administration 7 Humans 7 United States 5 Drug Approval 4 United States Food and Drug Administration 3 drug manufacture 3 drug marketing 3 randomized controlled trial (topic) 3 Adult 2 Middle Aged 2 Treatment Outcome 2 adult 2 clinical outcome 2 controlled study 2 cost benefit analysis 2 drug efficacy 2 drug quality 2 drug safety 2 generic drug 2 middle aged 2 priority journal 2 public health 2 risk assessment 2 treatment outcome 2 1 [4 [(4a hydroxy decahydroisoquinolin 2 yl)methyl] 2 aminophenyl] 2 minoethyl n [3 cyclopropylimidazo[1,5 a]pyridin 1 yl]carbamate 1 Accelerated approval 1 Adverse effects 1