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 Prepares To Issue Draft Biomarker Qualifications Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

The document should provide an "important boost" to employing genetic, genomic and protein-based markers to improve the efficiency of preclinical and clinical drug studies and make them more likely to succeed, Commissioner Hamburg told the Personalized Medicine Coalition.

You may also be interested in...



FDA Drug Development Tool Guidance Leaves Door Open For Advisory Committee Reviews

FDA’s proposed process for qualifying drug development tools allows for the convening of advisory committee meetings or other public discussions about complicated submissions involving proposed biomarkers or patient-reported outcome instruments.

FDA Drug Development Tool Guidance Leaves Door Open For Advisory Committee Reviews

FDA’s proposed process for qualifying drug development tools allows for the convening of advisory committee meetings or other public discussions about complicated submissions involving proposed biomarkers or patient-reported outcome instruments.

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

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS070456

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