Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

ABSTRACT:

Objective

To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades.

Design

Cohort study.

Setting

FDA approved novel therapeutics between 1987 and 2014.

Population

Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review.

Main outcome measures

Logistic regression models evaluated trends in the proportion of drugs associated with each of the fo

SUBMITTER: Kesselheim AS 

PROVIDER: S-EPMC4580726 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature