HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Supplement GMPs

This article was originally published in The Tan Sheet

Executive Summary

Proposed reg could face another long delay as it undergoes reexamination by FDA/HHS under Bush Administration following withdrawal from OMB Feb. 1 (1"The Tan Sheet" Feb. 5, In Brief). Reg may have to wait for new FDA commissioner and likely would be an issue at confirmation hearings, industry sources speculate. Last acting commissioner served approximately 20 months

You may also be interested in...



E'Ola Appealing $13.3 Mil. Ephedrine Supplement Verdict

A $13.3 mil. jury verdict for an Alaska woman who claimed her stroke was caused by ephedrine alkaloid-containing dietary supplements could open the door to new lawsuits against the industry.

Supplement GMPs

FDA's proposed reg "withdrawn by agency" Feb. 1, according to OMB Web site. Long-awaited reg, which was sent to OMB in November, is one of many rulemakings affected by Bush Administration memorandum stating no proposed or final regs at OMB should be sent to Office of Federal Register until "a department or agency head" appointed by President Bush "reviews and approves the regulatory action" (1"The Tan Sheet" Jan. 29, p. 3)

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS131659

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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