Product Complexity and Strategic Alliance on Drug Approval

Authors

Taoyong Su
Wanrong Hou, The University of Texas Rio Grande Valley
Edward Levitas
Sibin Wu, University of Texas – Rio Grande ValleyFollow

Document Type

Article

Publication Date

5-2021

Abstract

Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA). Moreover, we argue that this association is contingent on the types of strategic alliances (i.e., R&D alliance, Marketing alliance) of the focal firm in that those alliances help FDA and pharmaceutical companies achieve harmony. Using the approved drugs by FDA from 1999 to 2016 as the sample, our hypotheses are supported by the empirical analysis on US pharmaceutical firms. The findings have important implications to achieving harmony between pharmaceutical firms and regulatory agencies.

Comments

© The Authors 2021

Recommended Citation

Su, Taoyong; Hou, Wanrong; Levitas, Edward; and Wu, Sibin (2021) "Product Complexity and Strategic Alliance on Drug Approval," American Business Review: Vol. 24 : No. 1 , Article 3. DOI: 10.37625/abr.24.1.36-53

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

Publication Title

American Business Review

DOI

https://doi.org/10.37625/abr.24.1.36-53