FDA Modernization Act 2.0 approved

The FDA Modernization Act 2.0 was approved by the US House on 23rd December 2022. The Bill authorises the use of certain alternatives for animal testing to obtain an exemption from the FDA to investigate the safety and effectiveness of a drug. It also removes a requirement to use animal studies as part of the licensing process for a biological product that is a biosimilar or interchangable with another biological product.

The Bill, first introduced by Senator Dr Paul in October 2021 (https://www.paul.senate.gov/news/paul-booker-introduce-bipartisan-fda-modernization-act-end-animal-testing-mandates) was signed into law by President Biden 29th December 2022.

For the context of the amendments, see https://www.congress.gov/bill/117th-congress/senate-bill/5002