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# FDA New Alternative Methods Office Needed: Report
- URL: https://www.fdaweb.com/fda-new-alternative-methods-office-needed-report/
- Published: 2024-10-09T12:00:00.000Z
- Updated: 2026-09-14T14:43:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157952

The FDA Science Advisory Board New Alternative Methods (NAMs) Subcommittee says the agency should create a centralized office to coordinate work on NAMs to evaluate regulated products while reducing dependence on animal testing. A Regulatory Affairs Professional Society (RAPS) [report](https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period?utm%5Fmedium=email&utm%5Fsource=govdelivery) on the Science Board 10/7 meeting (includes links to the meeting notice and the subcommittee report), says the report said a centralized NAM office would “signal to critical stakeholders and partners FDA’s commitment and seriousness to drive change with the adoption of NAMs, as appropriate. This includes assuring impactful communication, focus, and driving effective partnerships.”

The report also recommends that FDA develop metrics that can be used to evaluate the impact of the agency’s investment in NAMs, create a uniform framework to qualify NAMs, create a transparent and scientifically rigorous process to evaluate product applications that use NAMs, invest in high-impact NAM initiatives that can be used in regulatory decisions, and compile a central NAMs database, the RAPS story says.

The subcommittee said NAMs could include technologies and methodologies such as *in vitro* tests, *in silico* computational models, biomarkers, and modified *in vivo* assays. The report says that regulated industries have already made advances and adopted some NAMs to screen and identify compounds used in applications for approval.

The NAM program was launched in 2022.