Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017-2019.

ABSTRACT:

Background

The US Food and Drug Administration's Breakthrough Therapy Designation (BTD) program is intended to facilitate and expedite development of investigational drugs to address unmet medical needs. The objective of this study is to provide an update on FDA's process for review of BTD requests.

Methods

We reviewed Center for Drug Evaluation and Research (CDER) decisions to grant or deny breakthrough therapy designation requests for non-oncology drugs or biological products ("drugs") from January 1, 2017, through December 31, 2019. Data collection included characteristics of the corresponding drug and condition, reasons for granting or denying breakthrough therapy status, reasons for rescinding or withdrawing breakthrough therapy status after a request was granted (if ap

SUBMITTER: Poddar A 

PROVIDER: S-EPMC10764372 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature