Journal article
Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?
Abstract
Drug regulatory agencies around the world have implemented programs to expedite drug development and review for promising new products for serious diseases. These programs are all intended to minimize delays in patient access to innovative medicines, and have used broadly similar strategies to shorten drug development and review timelines. However, they differ in many key respects, and some stakeholders have suggested that these differences …
Authors
Richardson E; Daniel G; Joy DR; Kweder SL; Maloney DM; Raggio MJ; Jarow JP
Journal
Therapeutic Innovation & Regulatory Science, Vol. 52, No. 6, pp. 793–798
Publisher
Springer Nature
Publication Date
November 2018
DOI
10.1177/2168479018764664
ISSN
2168-4790