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Regulatory Oversight › Pharmaceutical Industry › Clinical Laboratory Testing

Epstein Becker & Green

The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care

Epstein Becker & Green on

Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Bass, Berry & Sims PLC

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

Bass, Berry & Sims PLC on

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

McDermott Will & Emery on

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

Hogan Lovells on

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

Hogan Lovells on

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

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