The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions.

ABSTRACT:

Background

Despite the growing application of facilitated regulatory pathways (FRPs), little attention has focused on assessing the perception of pharmaceutical companies regarding their usefulness beyond increasing timeliness.

Objectives

The aim of this study was to characterize the perceived value of four key FRPs, based on industry experiences in using these pathways. In addition, we sought to characterize the perceived impact based on benefits and barriers as well as suggested solutions for their use and recommendations as identified by companies, to outline how these FRPs may be further evolved as tools for expediting the development and regulatory review of important medicines.

Methods

A study was undertaken to characterize the perceived value and impact of US F

SUBMITTER: Bujar M 

PROVIDER: S-EPMC7858039 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature