# FDA Updates Drug Testing Regulations

The U.S. Food and Drug Administration (FDA) has issued a direct final rule updating its regulations to formally recognize and permit the use of innovative non-animal testing methods, known as New Approach Methodologies (NAMs), for nonclinical safety testing of drugs and biological products. This regulatory change, aligned with the Food and Drug Omnibus Reform Act of 2022, provides drug developers and contractors greater flexibility in testing approaches, potentially accelerating drug development timelines while maintaining safety standards. The update clarifies terminology and supports modern scientific methods but does not eliminate the use of animal testing.

- **Why this matters:** Procurement professionals and contractors in pharmaceutical development and testing services should evaluate opportunities to offer or integrate NAM-based testing solutions that comply with the updated FDA regulations.
- This regulatory shift may influence contract requirements and evaluation criteria for nonclinical safety testing services, emphasizing innovative and alternative testing technologies.
- Organizations involved in drug safety testing can leverage this update to propose more efficient, scientifically advanced testing methodologies in upcoming solicitations.
- The FDA's Silver Spring, Maryland location remains a key hub for regulatory engagement and potential collaboration on implementation guidance.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Regulatory Compliance
**Published:** September 21, 2026

### Government Entities
- U.S. Food and Drug Administration (FDA)
- Department of Health and Human Services (HHS)

### Sources
- [FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing | FDA](https://www.fda.gov/news-events/press-announcements/fda-updates-regulations-advance-innovative-alternatives-animal-testing) - FDA