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

FDA supplement ombudsman

This article was originally published in The Tan Sheet

Executive Summary

Rep. Frank Pallone (D-N.J.) urges HHS Secretary Tommy Thompson to establish a dietary supplement ombudsman position at FDA, in Feb. 21 letter. Pallone states ombudsman "would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. [He] would help address the need for centralized authority and accountability within FDA." American Herbal Products Association called for a supplement ombudsman at FDA in a 2001 letter to the White House Commission for Complementary & Alternative Medicine (1"The Tan Sheet" July 30, 2001, In Brief). Pallone's letter also calls for the release of GMPs, noting they have been delayed numerous times...

You may also be interested in...



WHCCAMP

FDA should initiate a review process much like its ongoing OTC monograph review to evaluate botanicals and appoint a "dietary supplement ombudsman," American Herbal Products Association asserts in recent letter to White House Commission for Complementary & Alternative Medicine. AHPA maintains agency's August 2000 "Botanicals Drug Guidance" does not sufficiently address marketing botanicals with a long history of use as nonprescription drugs. WHCCAMP also should recommend FDA employ "responsible advocate" for supplement industry in its report to President. Interim report was scheduled for July 16, but has yet to be released (1"The Tan Sheet" July 9, p. 8)

QUOTED. 7 April 2020. Surendar Magar.

California-based biosensor patch company LifeSignals Group plans to file for an emergency use authorization from the US FDA for a new patch that can monitor vital signs to help individuals decide when to seek the help of a health care provider. See what LifeSignals’ CEO Surendar Magar said about it here.

EMA's Decision On Ranitidine Remaining Available Could Come At End Of April

Following the US request for ranitidine drugs to be withdrawn from the market, the European Medicines Agency says it would decide the fate of the products in the EU after wrapping up its own inquiry.

Topics

UsernamePublicRestriction

Register

PS095161

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