Jessica Tierney

Jessica Tierney

Jones Day

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Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more

7/29/2025  /  Drug Pricing , Health Insurance , Healthcare , Medicare , New Legislation , One Big Beautiful Bill Act , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Trump Administration

FDA Directed to Explore Elimination of Food Additive "Loophole"

Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....more

3/21/2025  /  Consumer Protection Laws , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Food Safety , Public Health , Regulatory Reform , Regulatory Requirements , Rulemaking Process

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

1/30/2025  /  Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Medicare , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform
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