Steve Satterfield

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NIH Once Again Rejects Call To Exercise March-In Rights

Last month, the National Institutes for Health once again rejected a petition requesting that the agency exercise its “march-in rights” under the Bayh-Dole Act for patents owned and used to manufacture an HIV drug, Norvir®.  The petition was the second to concern this product, and the fifth, of which we are aware, asking NIH to … Continue Reading

More Delays for the Vote on the New EU Regulations for Medical Devices and IVDs

The long awaited vote by the Environment, Public Health and Food Safety (ENVI) Committee, the lead European Parliament Committee overseeing the revision of EU medical devices legislation, on the European Commission’s proposals for a Regulation on medical devices and a Regulation on in vitro diagnostic medical devices has been delayed for a second time.  In … Continue Reading

CFDA Publishes Draft Rule on Administrative Procedure for Public Comment

The Chinese government is currently taking steps to strengthen CFDA’s authority as an agency within the Chinese government, while at the same time increasing regulatory transparency.  As part of this effort, the China Food & Drug Administration (CFDA) recently issued a proposed rule (Draft Rule) to revise its 2002 Provisions on Legislative Procedures, which sets … Continue Reading