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Regulatory Agenda › Laboratory Developed Tests › Clinical Laboratories

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 3 – Legal Challenges

Sheppard Mullin Richter & Hampton LLP on

This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration...more

McDermott Will & Emery

[Event] +Dx Forum 2023 - March 3rd, Washington, DC

McDermott Will & Emery on

+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more

Mintz - Health Care Viewpoints

Evolution & Revolution: Device Policy Priorities at FDA in 2019

Mintz - Health Care Viewpoints on

This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more

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