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

UsernamePublicRestriction

FDA’s Progress On Biomarkers: Two Steps Forward, One Step Back?

Executive Summary

FDA is moving ahead with its biomarker validation efforts with the establishment of a consortium with the Pharmaceutical Research & Manufacturers of America and NIH, but the agency has halted an internal biomarker survey in favor of a broader inventory of endpoints

You may also be interested in...



FDA Pushes Back Against “Living” Benefit-Risk Assessment Management Plan

The Institute of Medicine urges the agency to create a publicly available document setting forth benefits and risks of drugs, with periodic updates, but FDA says it has no extra resources to handle such an effort.

Critical Path Consortium To Allow Patents But Preserve Access For Partners

The Predictive Safety Testing Consortium will allow companies to patent safety testing methodologies developed through the collaboration, but firms will be required to grant access to other members

Critical Path Consortium To Allow Patents But Preserve Access For Partners

The Predictive Safety Testing Consortium will allow companies to patent safety testing methodologies developed through the collaboration, but firms will be required to grant access to other members

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS046592

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