FDA Releases Guidance on Developing Botanical Drugs

FDA’s Center for Drug Evaluation and Research (CDER) released guidance on Aug. 14, 2015 expressing the center’s thinking on development plans for botanical drugs submitted in new drug applications (NDAs). The guidance also presents recommendations for submitting investigational new drug applications (INDs) and may also apply to biologics license applications (BLAs). Information on the over-the-counter (OTC) drug monograph system for botanical drugs is also provided. The new guidance revises a June 2004 guidance due to improved understanding of botanicals and includes revised and new sections to address late-phase development and NDA submissions.

Because of the unique nature of botanical drugs, FDA has applied regulatory policies that are different from the ones that apply to nonbotanical drugs. FDA defines botanicals as “products that include plant materials, algae, macroscopic fungi, and combinations thereof.” The guidance specifically addresses marketing of botanical drugs under OTC drug monographs; marketing of botanicals under NDAs; botanical drug development under INDs; INDs for Phase I, II, and III clinical studies; and NDAs for botanical drug products.