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New Regulations › Department of Health and Human Services (HHS) › Pharmaceutical Industry

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Spilman Thomas & Battle, PLLC on

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021

Latham & Watkins LLP on

Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more

ArentFox Schiff

340B Entities Sue HHS Over Lack of Dispute Resolution Process

ArentFox Schiff on

Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

Mintz - Health Care Viewpoints on

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Bricker Graydon LLP

Federal appeals court rules against the American Hospital Association’s challenge to the $1.6 billion in Medicare 340B cuts

Bricker Graydon LLP on

On July 17, 2017, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the Department of Health and Human Services (HHS), finding that the American Hospital Association’s (AHA) legal challenge of...more

Morgan Lewis

HRSA Publishes Orphan Drug Rule for 340B Program

Morgan Lewis on

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

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