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

Lifecore Biomedical Warning Letter Spotlights Intergel Adverse Event Issues

This article was originally published in The Gray Sheet

Executive Summary

Lifecore Biomedical's efforts to bring its Intergel adhesion prevention solution back to the U.S. market may be slowed by a recent warning letter citing failure to report adverse events to FDA in a timely manner

You may also be interested in...



FDA Panel: Cardiac Surgery Adhesion Barrier Use Should Be Limited To Kids

SyntheMed's Repel-CV cardiac surgery adhesion barrier should be approved only for pediatric patients since pivotal trial data on newborns cannot be extrapolated to the adult population, FDA's Circulatory System Devices advisory panel recommended Sept. 19

FDA Panel: Cardiac Surgery Adhesion Barrier Use Should Be Limited To Kids

SyntheMed's Repel-CV cardiac surgery adhesion barrier should be approved only for pediatric patients since pivotal trial data on newborns cannot be extrapolated to the adult population, FDA's Circulatory System Devices advisory panel recommended Sept. 19

FDA Defends Its Line Of Communication As Lifecore Revamps MDR Procedures

Lifecore Biomedical had sufficient opportunity to obtain FDA guidance on medical device reporting (MDR) for theIntergel adhesion prevention solution, despite the firm's claims to the contrary, the agency maintains in a Dec. 1 letter

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT021181

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