Gregory Levine

Ropes & Gray LLP

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District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more

4/10/2025 / Administrative Procedure Act , Appeals , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medical Devices , Regulatory Authority , Statutory Interpretation , Vacated

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

1/31/2025 / Artificial Intelligence , Biden Administration , Data Management , Digital Health , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Pharmaceutical Industry , Regulatory Requirements , Risk Management , Transparency

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

1/16/2025 / Clinical Trials , Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , Office for Human Research Protections (OHRP) , Regulatory Agenda , Regulatory Requirements

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