Botanicals
This article was originally published in The Tan Sheet
Executive Summary
FDA guidance on OTC and Rx botanical drugs could be released this fall, Center for Drug Evaluation & Research Office of New Drug Chemistry Acting Director Yuan-yuan Chiu, PhD, says at the National Institutes of Health "Symposium on Complementary and Alternative Medicine in Chronic Liver Disease" Aug. 24. The guidance, in the works since 1994, is under review by FDA regulatory policy staff and legal counsel (1"The Tan Sheet," May 4, 1998, p. 7). Also, FDA's structure/function claims rule could be made final internally in September, Chiu says. The proposed rule's provisions on the definition of "disease," common conditions associated with natural states and implied disease claims were the subject of an Aug. 4 public hearing (2"The Tan Sheet" Aug. 9, pp. 6-10)
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FDA guidance on OTC and Rx botanical drugs could be released this fall, Center for Drug Evaluation & Research Office of New Drug Chemistry Acting Director Yuan-yuan Chiu, PhD, says at the National Institutes of Health "Symposium on Complementary and Alternative Medicine in Chronic Liver Disease" Aug. 24. The guidance, in the works since 1994, is under review by FDA regulatory policy staff and legal counsel (1 ). Also, FDA's structure/function claims rule could be made final internally in September, Chiu says. The proposed rule's provisions on the definition of "disease," common conditions associated with natural states and implied disease claims were the subject of an Aug. 4 public hearing (2 (Also see "Disclaimers May Be "Subterfuge" For Disease Claims, PhRMA Exec Warns" - Pink Sheet, 9 Aug, 1999.)). |