{Reference Type}: Journal Article
{Title}: FDA Modernization Act 2.0: An insight from nondeveloping country.
{Author}: Akash SR;Arnob MAJB;Uddin MJ;
{Journal}: Drug Dev Res
{Volume}: 84
{Issue}: 8
{Year}: 2023 Dec 17
{Factor}: 5.004
{DOI}: 10.1002/ddr.22108
{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.