Scrip 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

MDUFMA Performance Goals

This article was originally published in RAJ Devices

Executive Summary

GAO report finds US FDA review data too limited

You may also be interested in...



Dr Reddy’s Knocked Back On Rituximab In US

Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

Sandoz And Samsung Celebrate Stelara Rival’s EU Approval

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.

Second EU MDR Notified Body Designated In France

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.

Latest Headlines
See All
UsernamePublicRestriction

Register

SC093605

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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