Medtech 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


Reagan-Udall pushback

This article was originally published in The Gray Sheet

Executive Summary

Rep. Rosa DeLauro, D-Conn., wants FDA to halt efforts to establish the Reagan-Udall Foundation, a non-profit created by the recently enacted FDA Amendments Act. "The potential for pressure on FDA staff from Reagan-Udall Foundation-endorsed research is enormous," the chair of the House subcommittee overseeing FDA's budget writes in a Nov. 1 letter to Commissioner Andrew von Eschenbach. The foundation, to be funded from donations, patent revenue and FDA's budget, is tasked to work with FDA on its Critical Path initiative and other efforts to speed product development (1"The Gray Sheet" Oct. 8, 2007, p. 9). By law, four members of the yet-unnamed 14-person foundation board have to be from the device, drug, biotech, cosmetic and food industries

You may also be interested in...

Regulatory News In Brief

DeLauro targets ortho ads: Rep. Rosa DeLauro, D-Conn., says she may introduce a bill banning direct-to-consumer advertising for hip and knee implants for three years post-FDA approval. She has previously sponsored similar, unsuccessful legislation on drugs alone, but at an Oct. 3 speech at George Washington University, she cited a "new concern" with hip and knee ads "giving no indication of the potential complications and side effects from the major surgery they require." DeLauro, chair of the House appropriations panel that oversees FDA's budget, has noted that her own upcoming hip replacement surgery drew her to the issue. Her speech was mainly about a proposal to create a distinct Food Safety Administration and rename the rest of FDA the Federal Drug and Device Administration

Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease

Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.

Moderna CEO Hearing Highlights Dissatisfaction With Patient Assistance Programs

There was bipartisan agreement that Moderna need to ensure that its patient assistance program will be easily accessible for under- and uninsured patients once the US switches to a commercial market for COVID vaccines – a sign of broader frustration with industry copay support initiatives.

Latest Headlines
See All



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