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# Clarify Animal Testing Rules: Humane Society
- URL: https://www.fdaweb.com/clarify-animal-testing-rules-humane-society/
- Published: 2024-05-16T12:00:00.000Z
- Updated: 2026-09-14T14:31:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157006

The Humane Society of the United States is petitioning FDA to take specific steps to clarify agency rules on animal testing for the development and approval of drugs. The 5/15 [petition](ttps://downloads.regulations.gov/FDA-2024-P-2379-0001/attachment%5F1.pdf) specifically asks that FDA:

- amend current regulations that misleadingly suggest animal tests may be required for drug approval when they are not;
- issue a new guidance listing and detailing the new alternative methods accepted by the agency for approval of drugs for use by the regulated community; and
- include a directive about FDA’s acceptance of new alternative methods on all relevant current and future guidances.

“These actions will clarify rules for the regulated community,” the petition says, “potentially saving time and money in the development of new drugs; promote the use of the best available science to bring safe and effective drugs to the American people; and bring the agency’s regulatory landscape in line with its publicly stated goals and initiatives to reduce unnecessary, overly burdensome, and expensive animal testing. The changes requested in this petition will not require the use of one test method over another, but rather are intended to make clear to the regulated community the complete range of types of data accepted by the agency for the purposes of approving the use and marketing of drugs.”