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Biologic and Biosimilar Settlement Agreements Now Must Be Disclosed to DOJ and FTC

Recent amendments to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), titled the Patient Right to Know Drug Prices Act, require parties to inform regulatory authorities of executed settlement...more

Effective Immediately: The FDA Updates Humanitarian Device Exemption Regulations

On June 7, the U.S. Food & Drug Administration (FDA) announced that it is updating the humanitarian device exemption (HDE) regulations. The changes are meant to bring the regulations into compliance with the 21st Century...more

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