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

Califf Expected To Ace Senate Panel Vote, As He Ups Emphasis On Safety Surveillance

This article was originally published in The Gray Sheet

Executive Summary

The Senate Health, Education, Labor and Pensions Committee plans a confirmation vote on Robert Califf Jan. 12 to become the next FDA commissioner. Public health researchers and Sens. Sanders and Warren have argued that the long-time academic research leader's ties to industry are too close. Meanwhile, Califf recently has emphasized his focus on strengthening postmarket safety oversight.

You may also be interested in...



Califf Sets Departure From US FDA; Ostroff May Become Interim Leader

As FDA Commissioner Robert Califf prepares to step down from his post to make way for a Trump administration replacement, former Acting Commissioner Stephen Ostroff may step into the breach.

FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks

In a draft guidance, FDA explains how it plans to communicate signs of postmarket device risks before it has performed a full analysis or developed specific recommendations. Public health advocates say it is a positive move to get ahead of potential safety problems early. The agency is seeking comment from companies on whether it needs to consult with firms prior to releasing information on emerging signals about their devices.

Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing

Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034879

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