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.
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Biomarkers Qualification: Can FDA Get Rolling Before A Push From Congress?
FDA has been reluctant to lay out evidentiary standards for biomarker qualification, but its call for information on promising candidates may be an initial step toward creating such a framework.
What Not To Do: FDA Reviewer Talks Cancer Drug Development Mistakes
Using anonymous examples at the recent AACR meeting, FDA’s Tatiana Prowell highlights mistakes made and lessons learned in oncology drug reviews.
Disease-Of-The-Quarter Club: FDA Plans 20 Patient Network Meetings Over Five Years
PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.