Stage 3/Regulation (2) 썸네일형 리스트형 FDA U.S. Food and Drug Administration " FAQ on Botanical Drug Product Development " Frequently Asked Questions on Botanical Drug Product Development 1. Are Investigational New Drug (IND) applications required for clinical studies of botanical products that are also lawfully marketed as dietary supplements in the U.S.? Yes. If a lawfully marketed botanical dietary supplement is studied for its effects on diseases in the proposed investigation (i.e., to cure, treat, mitigate, pre.. 임상시험 및 신약개발과정 신약개발과정에 대해 잘 정리된 자료. Ref. www.nifds.go.kr 식품의약품안전평가원 www.discoverymedicine.com/ 이전 1 다음