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 Recalls List – January 14, 2015

This article was originally published in The Gray Sheet

Executive Summary

The agency's Jan. 14 enforcement report lists 44 device recalls including three class I actions from Alere.

You may also be interested in...



US DOJ Settles With St. Jude, Alere, Avanos For Total Of $88M

The settlements resolve False Claims Act allegations against St. Jude and Alere, as well as misbranding allegations against Avanos Medical.

Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials

The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.

Medicare Reaffirms Faith In Formulary Review Process Ahead Of Part D Changes

Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034443

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