IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible […]
- Regulatory Update
Response to FDA’s Gottlieb on Reducing Regulatory Burden
FDA chief’s ideas are positive for labs, but an expert said the details will matter
- By Joseph Burns
- > From the Volume XXV No. 6 - April 16, 2018 Issue
- Tags: american clinical laboratory, cap, cap and clia, clia, clinical lab, clinical laboratories, Clinical Laboratory, clinical laboratory industry, clinical laboratory tests, dark report, Diagnostic tests, gene sequencing, generation sequencing, in vitro diagnostic, lab developed tests, lab industry, lab test, laboratories, laboratory association, laboratory industry, laboratory tests, molecular tests, next generation sequencing, next-generation gene sequencing, pathologists, personalized medicine, the clinical laboratory, the dark report
