Labs and Industry Stakeholders Respond to FDA LDT Rule
Explore the response to the FDA's Laboratory Developed Tests, LDTs, final rule, including industry concessions, legal challenges, and legislative reactions.
Source: natlawreview.com
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Explore the response to the FDA's Laboratory Developed Tests, LDTs, final rule, including industry concessions, legal challenges, and legislative reactions.
Hi, I'm Greg Levine, head of the life sciences regulatory and compliance practice group in Ropes & Gray's Washington, D.C. office.
Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for...