Botanical drugs – what is the best way forward for regulatory and market approval?
European Pharmaceutical Review
JULY 4, 2024
1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. The MA pathway is applicable for herbal medicines designed to treat more serious health conditions and require a medical prescription or the supervision of a medical practitioner. 2012/1916). 2012/1916).
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