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

From nuts to drugs

Executive Summary

When the House Energy and Commerce Oversight Subcommittee turns its attention from salmonella-contaminated peanuts and inadequacies in the FDA system for monitoring food safety, CDER and Ranbaxy executives could be the next to feel the heat. Subcommittee Chairman Bart Stupak, D-Mich., already has an ongoing investigation into why FDA failed to remove Ranbaxy products from the market after it found GMP violations at a company plant in India in 2006 (1"The Pink Sheet," July 28, 2008, p. 27). A public review of findings from that inquiry would provide further impetus for action on the FDA Globalization Act introduced by Committee Chairman Emeritus John Dingell, D-Mich., with Stupak and Health Subcommittee Chair Frank Pallone, D-N.J. Action is needed "sooner rather than later to put the agency back on track in protecting the public from unsafe food and drugs," Stupak said Feb. 12 following a recall of all products made at the Peanut Corporation of America's Plainview, Tex., plant since its opening in 2005

You may also be interested in...



FDA Should Recall Drugs Subject To GMP Violations, Rep. Dingell Suggests

The House Energy & Commerce Committee is suggesting that it is not enough for FDA to send a warning letter to a company in violation of good manufacturing practices

ViiV Anticipates 10%-15% Switchover To Long-Term HIV Option Cabenuva

The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.

FDA Sets New Restrictions For Authorized N95 Decontamination Systems

After reviewing real-world data, the US agency says the decontamination systems should only be used for compatible facemasks and should not be used to clean a mask more than four times.

Topics

UsernamePublicRestriction

Register

ID007083

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