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Dr. Joel Zinberg appeared on the Federalist Society’s Fourth Branch Podcast – February 9, 2024

Director at Public Health and American Well-Being Initiative
Joel M. Zinberg, M.D., J.D. is the Director of the Public Health and American Well-Being Initiative at Paragon Health Institute, and a senior fellow with the Competitive Enterprise Institute. A native New Yorker, he recently completed two years as General Counsel and Senior Economist at the Council of Economic Advisers in the Executive Office of the President.

On February 9, 2024, Paragon’s Dr. Joel Zinberg appeared on the Federalist Society’s Fourth Branch Podcast to discuss the topic of his recent Paragon research paper “Unwise and Unauthorized: FDA Regulation of Laboratory Developed Tests.

Description from the Fourth Branch Podcast:

For many years FDA has claimed the authority to regulate Laboratory Developed Tests, that is tests that are designed, produced, and used in a single lab – never being put up for sale. This authority, however, has been contested, and the FDA itself has traditionally practiced “discretionary enforcement,” wherein it has regulated LDTs very little. A change occurred in October 2023 when the FDA issued a notice of proposed rulemaking wherein it indicated its intention to codify its claim of authority and begin enforcing oversight of LDTs. Dr. Joel Zinberg, M.D., J.D., joined us to discuss the history the FDA’s regulation of LDTs, the proposed rule, and what the ramifications may be.

The original posting of the podcast can be found here.

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