RAPS: FDA Looks to Develop Regulatory Strategies for Genomic Testing

To further the president\'s Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing (NGS) technologies. Since 2014, FDA has sought input from the public on how it could develop a regulatory system appropriate for reviewing and regulating NGS technologies. The agency says it believes such a system \"could potentially be applied to many other types of genomic tests.