WASHINGTON, Dec. 23, 2022 /PRNewswire/ — In a significant step for the advancement of human health, Congress passed the FDA Modernization Act as part of the FY2023 Omnibus Appropriations Bill. It is now being forward to President Biden’s desk to be signed into law.
In Section 3209 titled “Animal Testing Alternatives,” the bill amends the regulatory guidance at the FDA that requires animal testing for drugs and biosimilars. The bill amends the Federal Food, Drug, and Cosmetics Act (FFDCA) to:
Substitute the term “nonclinical tests” for the current “preclinical tests” (including tests on animals),
Substitute the term “animal” for “nonclinical tests” and,
Add a new section defining “nonclinical tests” to include human-relevant testing methods such as cell-based assays, microphysiological systems (such as Organ-Chips), or bioprinted or computer models.
