Craig Bleifer

Craig Bleifer

McGuireWoods LLP

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Latest Posts › Food and Drug Administration (FDA)

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Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

5/6/2025  /  Appeals , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Regulatory Requirements

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

1/30/2025  /  Centers for Medicare & Medicaid Services (CMS) , CMMI , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC , New Guidance , Pharmaceutical Industry
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