FDA Modernization Act 2.0: An insight from nondeveloping country

Author:

Akash Sajidur Rahman12ORCID,Arnob M. A. Jobayer Billah3,Uddin Md Jamal24ORCID

Affiliation:

1. Department of Pharmacy Bangladesh University Dhaka Bangladesh

2. ABEx Bio‐Research Center East Azampur Dhaka Bangladesh

3. Department of Biomedical Engineering Chittagong University of Engineering & Technology Chittagong Bangladesh

4. Graduate School of Pharmaceutical Sciences Ewha Womans University Seoul Korea

Abstract

AbstractAnimal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new insight into drug development. It opens a new door by offering an alternative testing method for developing a new drug without using animals. This newly proposed system may potentially significantly impact nondeveloped countries worldwide. In this study, we explore the alternative testing options such as in silico modeling, human tissue‐on‐chip engineering, animal‐free recombinant antibodies, tissue engineering, and artificial intelligence presented by this act and discuss its implications for nondeveloped countries.

Publisher

Wiley

Subject

Drug Discovery

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