News & Analysis as of

HRSA Department of Health and Human Services (HHS) New Regulations

Alston & Bird

Health Care Week in Review | HHS Announces Significant Workforce Reductions and Reorganization; FDA and NIH Nominees are Confirmed

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

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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