This presentation will provide an overview of FDA regulation of diagnostics, particularly companion diagnostics. It will address research and development considerations such as investigational device exemption requirements and the potential regulation of investigational diagnostics during clinical trials of therapeutic products. The presentation will also highlight recent regulatory shifts, including the fallout from the rejection of FDA's final rule on lab-developed tests.   These topics are relevant to health law practitioners advising on biopharma, diagnostic, or clinical research issues in today’s rapidly evolving regulatory landscape.

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