The FDA issued a request for information aimed at accelerating development and review of botanical drug products in the U.S. The agency is seeking input on challenges sponsors face and potential solutions, as it looks to facilitate additional research and clarify regulatory expectations. The notice was published in the Sept. 4 Federal Register and signals the FDA’s willingness to engage directly with how botanical products are evaluated for quality, consistency, and clinical evidence. For botanical developers and contract manufacturing organizations, the RFI is a near-term signal to prepare for more structured pathways covering evidence packages, analytical methods, and review timelines. In an environment where rare and novel modalities often dominate headlines, the move also expands regulatory attention to complex natural products as legitimate drug candidates.