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

UsernamePublicRestriction

FDA Nominee Califf Seeks Clinical Trial, Combo Product Reforms

This article was originally published in The Gray Sheet

Executive Summary

President Obama nominated Robert Califf for FDA commissioner, and Senate HELP Chairman Lamar Alexander said the committee "will move promptly" to consider the nomination. If confirmed, he would be expected to lead reforms of the combination products review process, among other initiatives. However, while the initial positive response from Sen. Alexander suggests the possibility of a smooth confirmation, it certainly isn't guaranteed.

You may also be interested in...



Commissioner Califf: Cardiologist, Clinical Trials Expert Ascends At FDA

The Senate confirmed Robert Califf as the new FDA commissioner after months of delay, giving the cardiologist, clinical trial expert and established agency official a better platform to push his priorities, which include combination product and clinical data-collection reforms, while implementing projects already under way.

In Case You Missed It: Top 10 "Gray Sheet" Stories In September

Our most popular stories last month focused on tips from FDA experts on facility inspections, various legal trends, and Robert Califf's nomination to head FDA, among other topics.

Consumer Groups Oppose Califf To Head FDA, Citing Industry Ties

Groups including Public Citizen say the Senate should reject the president's nomination of clinical trials expert and cardiologist Robert Califf as FDA commissioner due to his prior financial ties to industry. "The Gray Sheet" takes a look at his financial conflict of interest forms from former employer Duke University, which show relationships with a range of manufacturers – although more are from the pharmaceutical arena than the medical device space. But entries in Duke University’s conflict-of-interest disclosures don't always match up to those in the government's Open Payments database.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034208

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