FDA Aspergillosis Biomarker Qualification Highlights New Drug Development Tool Process
This article was originally published in RPM Report
FDA’s new drug development qualification process offers a pathway for outside groups to gain acceptance of specific biomarkers for regulatory purposes. FDA recently used the process to qualify a specific biomarker for a severe fungal infection.
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Accelerated Approval For Biomarkers? FDA Considers “Limited Context of Use” To Shorten Qualification Process
Biomarker qualification is a hot topic for FDA, industry and Congress, based on the premise that better methods to develop and apply novel biomarkers can be the next big step in helping usher in an era of personalized medicine. One common argument is that the current FDA qualification process is too long. FDA is eager to change that perception.
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.
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