US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) grants accelerated approval according to surrogate measures of numerous drug indications for serious or life-threatening illnesses such as infectious diseases and cancer. Investigators, including the FDA, have evaluated the program's regulatory and clinical consequences in oncology, but evaluation of nononcology drugs is lacking.

Objective

To evaluate the accelerated approval program for nononcology drug indications over a period of 26 years.

Design, setting, and participants

This retrospective cohort study used publicly available data on FDA nononcology drug indications granted accelerated approval from June 1992 through May 2018, with preapproval and confirmatory trials for approved drugs. Data were analyzed from

SUBMITTER: Omae K 

PROVIDER: S-EPMC9463606 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature