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FDA’s Regulation of Laboratory Developed Tests—Where Do We Go Next?


The FDA has shown growing interest in regulating laboratory developed tests (LDTs) to ensure their safety and effectiveness.

The FDA’s intent has reached a crucial point as evident by the recent issuance of a draft framework for regulating LDTs. Laboratories and related stakeholders fear that the cost to manufacture LDTs will skyrocket due to the need for clinical trials, which will stifle innovation. Providers and laboratorians also worry that the FDA does not have the resources to regulate all LDTs, and the delays will potentially endanger patient care.

In this webinar, panelists discuss:

  • The FDA’s jurisdiction and draft framework for regulating LDTs
  • The role of Clinical Laboratory Improvement Amendments (CLIA) in regulating tests
  • What’s next in regulating next-generation sequencing-based tests

Panelists include: Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health; Roger Klein, MD, JD, Medical Director of Molecular Oncology, Cleveland Clinic Foundation; Andrew Fish, JD, Executive Director, AdvaMedDx.

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