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OIG approves arrangement involving free drug samples for inpatient hospital use

USA - January 24 2023 On December 28, 2022, the Department of Health and Human Services' Office of Inspector General (OIG) issued a favorable Advisory Opinion on a…

Madhav Y. Bhatt, Sonia T. Nguyen

HHS Proposes Rule to Update Retail Pharmacy Standards for Electronic Transactions under HIPAA

USA - December 9 2022 The Department of Health and Human Services (“HHS”) has proposed a rule that updates retail pharmacy standards for electronic transactions adopted…

OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard

USA - March 28 2022 The Occupational Safety and Health Administration (“OSHA”) has reopened the comment period on its June 2021 interim final rule establishing an…

Nicole J. Aiken-Shaban, James A. Holt, Matthew K. Loughran, Whitney Petrie

Competing bills propose amendments to FDA’s accelerated approval program

USA - March 18 2022 The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”) Accelerated Approval…

Taber Rueter