高通量测序培训班10-Introduction of US FDA High Throughput Sequencing Kit JMS NICPBPMay 8 2....pdfVIP

Introduction of US FDA High Throughput Sequencing Kit Review Jody Schulz and Approval Sr. Manager, Regulatory Affairs Thermo Fisher Scientific NICPBP May 23, 2018 Proprietary Confidential The world leader in serving science Overview Agenda 1. Overview of US FDA Next Generation Sequencing regulations a. History (timeline of regulation development) b. Industry feedback on development of regulations c. NGS regulation sequencer regulation overview in the United States 2. United States FDA: Ensuring safety and effectiveness of NGS product design and manufacturing 3. NGS manufacturer adjustment to US FDA regulations 4. Overview of Companion Diagnostic (CDx) co-development with therapies a. Clinical trial design and FDA submission process for drugs with CDx’s b. Interaction between drug and device submission within FDA 5. NGS Oncology assay regulation overview in the US a. Examples of studies required for an NGS assay submission in the US 2 Proprietary Confidential Overview of US FDA Next Generation Sequencing regulations • The FDA uses a variety of sources to obtain information when establishing a regulatory frame work for new device types including as follows: • Working groups (meetings with industry leaders who’s meeting minutes are public) • Top research institutions