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Federal Court Affirms HRSA Authority to Preapprove 340B Rebate Models but Urges HRSA to Reconsider Rejection of Rebate Model

In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

DEA Proposes Three-Tiered Special Registration System for Prescribing and Dispensing of Controlled Substances

On January 15, 2025, the Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) issued a series of rules relating to the telemedicine prescribing of controlled substances, including a proposed...more

Cybersecurity Toolkit for Healthcare and Public Health Sector

On November 1, 2023, the Cybersecurity and Infrastructure Security Agency (“CISA”) and the Department of Health and Human Services (“HHS”) co-hosted a roundtable discussion on the cybersecurity challenges that the US...more

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