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# FDA Promotes New Approaches to Animal Drug Approval
- URL: https://www.fdaweb.com/fda-promotes-new-approaches-to-animal-drug-approval/
- Published: 2021-10-05T12:00:00.000Z
- Updated: 2026-09-14T17:17:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150287

Center for Veterinary Medicine (CVM) director **Steven Solomon** says FDA has released four final [guidances](https://www.fda.gov/animal-veterinary/cvm-updates/fda-issues-draft-guidances-help-facilitate-development-new-animal-drug-submissions?ref=fdaweb.com) describing pathways for animal drug sponsors to use new approaches like adaptive study designs, real-world evidence, and biomarkers to establish drug effectiveness. The documents also offer more detailed guidance on how to leverage data collected from foreign countries to support approval of their products in the U.S., he says.

In a [statement](https://www.fda.gov/news-events/fda-voices/advancing-development-innovative-veterinary-products?utm%5Fmedium=email&utm%5Fsource=govdelivery), Solomon says the guidances “encourage animal drug sponsors to consider these innovative approaches as they prepare data submissions related to new animal drug products for agency evaluation and review, as part of FDA’s new animal drug approval process. The recommendations in these guidance documents closely align with those already issued by FDA’s other medical product Centers.”