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# FDA Wants Botanical Drug Development Input
- URL: https://www.fdaweb.com/fda-wants-botanical-drug-development-input/
- Published: 2026-09-03T12:00:00.000Z
- Updated: 2026-09-14T12:05:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161727

FDA is seeking public input and comments on its efforts to advance the development of botanical drug products (BDPs). A *Federal Register* [notice](https://www.federalregister.gov/public-inspection/2026-18133/request-for-information-advancing-development-of-botanical-drug-products?utm%5Fmedium=email&utm%5Fsource=govdelivery) to be published on 9/4 says the agency wants to “better understand stakeholders’ perspectives on the state of BDP development in the U.S., challenges encountered, and potential solutions to gathering the information required by the Federal Food, Drug, and Cosmetic Act.”

In an agency [news release](https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-advance-development-botanical-drug-products?ref=fdaweb.com) announcing the Request for Information, FDA acting commissioner **Kyle Diamantas** says the Trump administration is committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science. “Botanical drug products represent a critical area where greater scientific development can unlock new therapeutic opportunities for American patients while maintaining the highest safety standards,” he says.

The public will have 60 days to provide feedback on topics such as challenges encountered in botanical research and drug development, innovative approaches to support and accelerate development, potential updates to FDA guidance and other resources, quality standards, appropriate study designs for complex botanical mixtures, and the potential use of real-world evidence and other scientifically credible information to facilitate development.

The release says FDA will convene a 9/25 joint workshop with the European Medicines Agency to discuss regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use.