FDA’s Woodcock Cautions Efforts To 'Legislate A New Generation Of Biomarkers'
This article was originally published in The Pink Sheet Daily
Executive Summary
New approaches to biomarker qualification is big part of industry’s agenda for '21st Century Cures,' but CDER Director Janet Woodcock remains concerned about efforts to legislate ahead of the science.
You may also be interested in...
US FDA Targets Migraine, Schizophrenia And Opioid Sparing Drugs For Clinical Outcome Assessment Development
Grant solicitation, a different approach than agency has so far taken with biomarkers, signals growing importance of patient input in drug development.
PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?
Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.
Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.