S. 355: FDA Modernization Act 3.0
Sponsor
Cory Booker
Democrat · NJ
Bill Progress
Latest Action · Dec 17, 2025
Passed the Senate, received in House
Why it matters
If this passes, drugmakers, biotech firms, and developers of organ-on-a-chip, computational, and other alternative testing tools would get something they have been demanding for years: clearer FDA rules instead of vague encouragement. That could speed some preclinical programs, reduce animal use, and lower development costs, while putting pressure on regulators and traditional animal-testing vendors who benefit from the status quo; the real test is whether the final rule is strong enough to change review culture, not just check a statutory box.
S. 355 Common Questions
How long would the FDA have to issue rules on nonclinical testing under S355?
Under the FDA Modernization Act 3.0 (Section 2), HHS must publish an interim final rule within 1 year of enactment.
Does FDA Modernization Act 3.0 make the new nonclinical testing rule effective immediately?
Yes. Under the FDA Modernization Act 3.0 (Section 2), the interim final rule takes effect immediately upon issuance.
Can the FDA skip the usual good cause showing to make the nonclinical testing rule effective right away?
Yes. According to S355 Section 2, the Secretary does not have to show "good cause" under 5 U.S.C. 553(b) for immediate effectiveness.
What FDA regulations would S355 change from animal testing language to nonclinical testing language?
Section 2 of the FDA Modernization Act 3.0 directs amendments across 21 CFR Parts 312, 314, 315, 330, and 601, replacing references to "animal" tests, data, studies, models, and research with "nonclinical."
Which FDA code sections would get a definition of nonclinical test under FDA Modernization Act 3.0?
Under the FDA Modernization Act 3.0 (Section 2), the definition of "nonclinical test" would be added to 21 CFR 312.3, 314.3, 315.2, and 601.31.
Can drug companies use non-animal preclinical tests in FDA submissions under S355?
S355 Section 2 would align FDA regulations with FDCA section 505(i) by replacing animal-testing references with nonclinical-testing terms, supporting use of non-animal methods in covered submissions.
Does FDA Modernization Act 3.0 affect biologics as well as drugs?
Yes. Under Section 2, S355 amends regulations including 21 CFR 601.31 and 601.35(d), so the nonclinical-testing updates reach biologics as well as drug regulations.
Does S355 change FDA rules for over-the-counter drug monographs too?
Yes. According to S355 Section 2, 21 CFR 330.10(a)(2) is among the sections that must be amended for consistency with nonclinical testing terminology.
What are the specific IND and NDA regulations S355 would amend for nonclinical testing?
Under Section 2 of the FDA Modernization Act 3.0, S355 specifically lists IND sections in 21 CFR Part 312 and NDA/ANDA sections in 21 CFR Part 314 for amendment.
Does FDA Modernization Act 3.0 rename the second FDCA subsection 505(z)?
Yes. Section 2 of the FDA Modernization Act 3.0 redesignates the second subsection 505(z), the one on clinical trial diversity action plans, as subsection 505(aa).
Based on S. 355 bill text
S355 Legislative Journey
House: Action Taken
Dec 17, 2025
Held at the desk.
Passed
Dec 16, 2025
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
+4 more actions this day
Committee Action
Feb 3, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
About the Sponsor
Cory Booker
Democrat, NJ · 13 years in Congress
Committees: Small Business and Entrepreneurship, Agriculture, Nutrition, and Forestry, Foreign Relations
View full profile →
Cosponsors (9)
This bill has 9 cosponsors: 4 Democrats, 4 Republicans, 1 Independent, reflecting bipartisan support. Cosponsors represent 9 states: California, Connecticut, Kansas, and 6 more.
Committee Sponsors
Health, Education, Labor, and Pensions Committee
2 of 23 committee members cosponsored
10 Democrats across this committee haven't cosponsored yet. Mobilize their constituents
S. 355 Quick Facts
- Committee
- Health, Education, Labor, and Pensions
- Chamber
- Senate
- Policy
- Health
- Introduced
- Feb 3, 2025
Passed the Senate, received in House
Dec 17, 2025
S. 355 Bill Text
“To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.”
Source: U.S. Government Publishing Office
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