FDA pencils in two public meetings for NGS regulation

The FDA is exploring new ways to beef up its oversight of next-generation sequencing (NGS) products, issuing a discussion paper last December about creating a new regulatory system for the tools and holding a workshop earlier this year to get feedback from the community. Now the agency is building on these efforts, planning to hold two back-to-back public workshops on Nov. 12 and 13 to discuss challenges in regulating NGS tests and ways to develop evaluation standards. In particular, regulators will lay out how scientists, patient groups and industry players can establish clinical databases with genomic information to track certain diseases. "We believe that stakeholder input about ongoing community standardization efforts is essential to construct flexible analytical evaluation approaches for a wide variety of NGS tests and modifications," the FDA said in a blog post. Blog post