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# FDA Grants, Denies Draize Test Petition
- URL: https://www.fdaweb.com/fda-grants-denies-draize-test-petition/
- Published: 2024-03-21T12:00:00.000Z
- Updated: 2026-09-14T14:26:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156605

FDA has granted in part and denied in part a 2016 petition from the Center for Responsible Science asking that the agency issue a guidance communicating broadly that it will accept *in vitro* primary skin and eye irritation data and that *in vivo* rabbit ocular and skin irritation tests (Draize) are no longer recommended. The agency [response](https://downloads.regulations.gov/FDA-2016-P-1314-0005/attachment%5F1.pdf?ref=fdaweb.com) says the petition is granted to the extent that FDA no longer recommends Draize testing for skin or eye irritation for drugs. In all other respects, the petition is denied.

The response says FDA does not require or recommend Draize testing for human drug development and has developed guidance that provides recommendations on local tolerance testing by means other than the Draize dermal or ocular toxicity tests. It also says FDA does not believe that further guidance is needed on the issue.