Volume 84, Issue 8 p. 1572-1577
COMMENTARY

FDA Modernization Act 2.0: An insight from nondeveloping country

Sajidur Rahman Akash

Sajidur Rahman Akash

Department of Pharmacy, Bangladesh University, Dhaka, Bangladesh

ABEx Bio-Research Center, East Azampur, Dhaka, Bangladesh

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M. A. Jobayer Billah Arnob

M. A. Jobayer Billah Arnob

Department of Biomedical Engineering, Chittagong University of Engineering & Technology, Chittagong, Bangladesh

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Md Jamal Uddin

Corresponding Author

Md Jamal Uddin

ABEx Bio-Research Center, East Azampur, Dhaka, Bangladesh

Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul, Korea

Correspondence Md Jamal Uddin, ABEx Bio-Research Center, East Azampur, Dhaka 1230, Bangladesh.

Email: [email protected]

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First published: 17 August 2023

Abstract

Animal 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.

CONFLICT OF INTEREST STATEMENT

The authors declare no conflict of interest.

DATA AVAILABILITY STATEMENT

Data sharing is not applicable to this article as no data sets were generated or analyzed during the current study.