Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.

ABSTRACT:

Importance

Since the introduction of the Fast Track designation in 1988, the number of special regulatory programs available for the approval of new drugs and biologics by the US Food and Drug Administration (FDA) has increased, offering the agency flexibility with respect to evidentiary requirements.

Objective

To characterize pivotal efficacy trials supporting the approval of new drugs and biologics during the past 3 decades.

Design, setting, and participants

This cross-sectional study included 273 new drugs and biologics approved by the FDA for 339 indications from 1995 to 1997, from 2005 to 2007, and from 2015 to 2017.

Main outcomes and measures

Therapeutics were classified by product type and therapeutic area as well as orphan designation and use of special

SUBMITTER: Zhang AD 

PROVIDER: S-EPMC7175081 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature