Biomarker Qualification: FDA Explains Process and Opportunities for Engagement
By Michael Mezher -
Published 19 September 2017
In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory strategy
Tags: Biomarkers, Biomarker Qualification Program, Critical Path Innovation Meeting, 21st Century Cures
FDA Offers Biomarker Qualification Case Studies
By Zachary Brennan -
Published 14 June 2017
As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.
Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development
Tags: biomarker qualification, FDA case studies, biomarkers, drug development
FDA, NIH Unveil Initial Framework for Biomarker Qualification
By Zachary Brennan -
Published 12 December 2016
Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for the proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs.
Categories: News, US, FDA, Clinical, Compliance, Drugs, Regulatory intelligence, Regulatory strategy
Tags: biomarker, biomarker qualification, 21st Century Cures, Woodcock, evidentiary criteria
Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)
By Alexander Gaffney, RAC -
Published 07 October 2014
The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Institute (C-Path), a decade-old effort to accelerate drug development through the use of common standards.
Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs
Tags: Guidance, Draft Guidance, C-Path, Critical Path Initiative, Critical Path Institute, Critical Path Innovation Meetings, CPIM, DDTs, Drug Development Tools, Biomarker Qualification