In The News

In Law360, LSRC Attorneys Examine HHS Announcement Barring FDA from Requiring Premarket Review for Laboratory-Developed Tests

Practices: Health Care, Life Sciences, FDA Regulatory, Digital Health, Clinical Research

Life sciences regulatory & compliance partner and chair Greg Levine, counsel Beth Weinman and associates Joshua Oyster and Steven Gonzalez (all of Washington, D.C.) co-authored a Law360 article that examines the likely impact, both during and after the COVID-19 pandemic, of a recent U.S. Department of Health and Human Services announcement preventing FDA from insisting on premarket review for laboratory-developed tests absent notice and comment rulemaking.

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