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Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Biden Administration Releases Draft Framework for Exercising Bayh-Dole March-in Rights Taking Into Account Drug Prices

On December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...more

The Health Care Priorities of the Biden Harris Administration and Post Election Outlook for the 117th Congress

In a historic presidential election that began during the COVID-19 pandemic and ended with record voter turnout and mail-in ballots, former Vice President Joseph Biden of Delaware was declared the 46th president of the United...more

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