Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)

You may also be interested in...



Disclaimers May Be "Subterfuge" For Disease Claims, PhRMA Exec Warns

FDA should be cautious in allowing a disclaimer statement that could mislead consumers into believing dietary supplements can cure or prevent disease, a PhRMA rep maintained at FDA's Aug. 4 public meeting on the regulation of supplement structure/ function claims in Washington, D.C.

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Topics

UsernamePublicRestriction

Register

PS090239

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel