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Clinical Laboratories › Regulatory Requirements › Regulatory Agenda

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

Morrison & Foerster LLP on

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

McDermott Will & Emery

What the New CLIA Rules Mean for Labs and At-Home Testing

McDermott Will & Emery on

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more

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

Nelson Mullins Riley & Scarborough LLP

CMS Delays Clinical Laboratory Proficiency Testing Rulemaking by a Year

Nelson Mullins Riley & Scarborough LLP on

The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year. ...more

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