Pink Sheet 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

DeLauro wants FDA approvals list

This article was originally published in The Tan Sheet

Executive Summary

Concerned that commercial and political interests "permeated the culture" of FDA and led to the approval of unsafe or ineffective products, Rep. Rosa DeLauro, D-Conn., requests the agency list all drugs, devices and biologics it approved or cleared in the final three months of the Bush administration. The chairwoman of the Appropriations subcommittee with FDA oversight also asks acting FDA Commissioner Frank M. Torti in a Feb. 12 letter about agency decisions about the generally recognized as safe status for food products made between November 2008 and January 2009. FDA has until Feb. 26 to respond to DeLauro's request, which follows a January letter from agency scientists that "corrupt" FDA managers pushed approval of questionable products (1"The Tan Sheet" Jan. 19, 2009, p. 16)

You may also be interested in...



DeLauro Adds FDA Scientists’ Complaint To Her List Of Agency Problems

FDA scientists' recent complaint to the Obama transition team that the agency is "fundamentally broken" adds fuel to Rep. Rosa DeLauro's fire to establish separate food and drug agencies

Can Organovo Leverage Its Solid Phase II Data In MASH?

Cash-limited Organovo has an FXR agonist showing competitive efficacy and tolerability in MASH, but may need a partner to move forward in that disease as it may be prioritizing its IBD program.

Cullinan Changes Tracks, Moving Lymphoma Bispecific Into Autoimmune

The company will discontinue its trial of the CD19-directed bispecific CLN-978 in NHL and develop it in inflammatory diseases, where it could have an edge over CAR-Ts.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS102604

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