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Manufacturers Audits Corrective Actions

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Baker Donelson

HRSA Guidance Updates Suggest Tightening of 340B Covered Entity Repayment Rules

Baker Donelson on

Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more

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