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

Nephrotoxicity Biomarkers To Be Test Run For FDA Qualification Program

Executive Summary

ATLANTA - A set of nephrotoxicity biomarkers will be the first submission considered by an FDA pilot program for qualifying biomarkers

You may also be interested in...



Biomarker Qualification Should Be Multi-Step Process, Regulators Say

U.S. and European regulations expect qualification of biomarkers for clinical use to be a multi-stage process that incrementally broadens a marker's application

Biomarker Qualification Should Be Multi-Step Process, Regulators Say

U.S. and European regulations expect qualification of biomarkers for clinical use to be a multi-stage process that incrementally broadens a marker's application

Regulatory Workaround, Not Statutory Changes, Better For Personalized Medicine Development, FDA Commissioner Hamburg Says

FDA Commissioner Margaret Hamburg said that working within the current regulatory framework rather than seeking new statutory authority to address the development of drugs and accompanying diagnostic tests would be preferable to address personalized medicine questions at the agency

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS048544

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