FDA

Drug development is a challenging and time-consuming procedure. An unmet medical need is a condition, the cure or diagnosis of which is not being addressed effectively by currently available therapies. To meet such an unmet medical need and treat severe diseases, Fast Track approval process has been introduced by Food and Drug Administration (FDA), which […]

A recently published study by Dyer O (2017) exposed major drawbacks in the accelerated approval process of some drugs available to the American patients without any stringent clinical evidence of their benefits. (1) Drugs receiving fast track approvals from the US Food and Drug Administration (FDA) often rest on a weak evidence base, says research […]