Pink Sheet 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


FDA/CMS Parallel Review Not Needed For Biopharma Products – PhRMA And BIO

Executive Summary

The two major trade associations representing drug and biological manufacturers are telling FDA and CMS that their proposed parallel review process is neither appropriate nor necessary for biopharma products.

You may also be interested in...

IPAB Raised At Debate, But Romney Advisor Skeptical Board Will Meet Even If Obama Wins

Strict conflict-of-interest restrictions will make it very challenging to get people confirmed to serve on the Independent Payment Advisory Board established under the 2010 health reform law, according to a top health care advisor to Mitt Romney. IPAB was addressed in the Oct. 3 presidential debate.

Medicare CED’s Possible Link With Expedited Drug Approvals Could Arise At MedCAC Review

At its next meeting May 16, the Medicare Evidence Development and Coverage Advisory Committee will hear from former CMS and FDA head Mark McClellan, who has supported the notion of linking Medicare’s coverage with evidence development tool with accelerated drug approvals.

CMS Guidance On Desired Data Might Meet The Goals Of Parallel Review More Reasonably, Former Official Gottlieb Suggests

AEI's Scott Gottlieb, a former official at FDA and CMS, offers his insights into the proposed parallel review program during Avalere conference.

Related Content


Latest Headlines
See All



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