1. Short title
This Act may be cited as the “FDA Modernization Act 2.0”.
FDA Modernization Act 2.0
AN ACT
To allow for alternatives to animal testing for purposes of drug and biological product applications.
2. Alternatives to animal testing
in subsection (i)—
in paragraph (1)(A), by striking “preclinical tests (including tests on animals)” and inserting “nonclinical tests”; and
in paragraph (2)(B), by striking “animal” and inserting “nonclinical tests”; and
after subsection (y), by inserting the following:
“(z) Nonclinical test defined—For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models.”
Biosimilar biological product applications— Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows:
“(bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and”