Technology

FDA Modernization Act 2.0

The new law amends the Federal Food, Drug, and Cosmetic Act by authorizing sponsors of novel drugs to, including cell-based assays and computer models, to obtain an exemption from make use of certain alternatives to animal testing the FDA to investigate the safety and effectiveness of a drug. It also removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product