The FDA has announced a request for information to gather public input on ways to advance the development of botanical drug products, according to a Sept. 3 agency news release.
Botanical drug products are derived from plant materials, algae or macroscopic fungi and are intended to diagnose, cure, mitigate, treat or prevent disease. The FDA said the products’ inherent complexity and variability create unique challenges for research, product development and regulatory review.
“Under the Trump administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science,” said Acting FDA Commissioner Kyle Diamantas. “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.”
Marta Sokolowska, PhD, deputy center director for substance use and behavioral health in the FDA’s Center for Drug Evaluation and Research, said the agency wants to hear from researchers, clinicians and industry about barriers to bringing safe and effective botanical drugs to patients.
Four botanical products have been approved for marketing as prescription drugs through the FDA’s new drug application and biologics license application pathways. The FDA will also hold a joint workshop with the European Medicines Agency on Sept. 25 to discuss regulatory considerations for herbal medicinal and botanical drug products.
The public has 60 days from the request’s publication in the Federal Register to submit comments to Docket No. FDA-2026-N-9550. The comment period closes Nov. 3.
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