Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Warning Letter Roundup & Recap –December 22, 2015

This article was originally published in The Gray Sheet

Executive Summary

Device firm Elite Massagers received two complaints – including one that described a user being shocked by an Elite Multi device – yet failed to investigate; Dutch Ophthalmic Research Center cited for premarket violations. Two device warning letters were listed by FDA last week.

You may also be interested in...



RedHill On The Rise With Three Drugs And Potential COVID-19 Therapy

The Israeli biotech which is listed on the NASDAQ is in for a busy 2021 with strong marketing pushes for Movantik, Aemcolo and Talicia and completing a pivotal trial for COVID-19 hopeful opaganib.

Pipeline Watch: Phase III Starts In PAH, NSCLC And Seizure Disorders

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Billionaire Mark Cuban Surprises With US Generics Venture

 To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022. 

Topics

UsernamePublicRestriction

Register

PS063835

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