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

US companies disagree over what the mutual recognition agreement with the EU might mean for them

This article was originally published in Clinica

Executive Summary

Not all US medical technology companies are enthusiastic about the pending mutual recognition agreement between the US and the European Union. Karen Riley reports from the Health Industry Manufacturers Association annual meeting last week in Rancho Mirage, California.

You may also be interested in...



Warning Letter Roundup & Recap – 8 April 2020

Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.

Expanding The Tent: Improving Trial Participation Among Under-Represented Patient Populations

The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later.

Wave Of Launches Boosts US Biosimilars Market

A flurry of US biosimilar launches over the past few months has opened several molecules to true, multi-source competition, with a range of pricing strategies seen from competitors. However, some brands that already face biosimilar competition elsewhere in the world are still poised to enjoy a significant period of exclusivity in the US, such as AbbVie’s Humira.

Topics

UsernamePublicRestriction

Register

MT080932

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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