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FDA seeks public input on botanical drug development

A photo of a moth pollinating a purple flower with a blurry green background.
Photo: Finnbarr Webster/Getty Images

FDA issues a request for information to gather feedback on challenges, scientific needs, and regulatory approaches for advancing botanical drug products.

Aiming to help shape future regulatory and scientific approaches for botanical drug development, the US Food and Drug Administration (FDA) has issued a public request for information.

Botanicals are plant‑based materials – like leaves, roots, bark, flowers, or extracts – that are used in science, medicine, and research because they

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