Health Care Law News and Insights

In January 2019, FDA issued an update to the Working Model for its Software as a Medical Device ("SaMD") Precertification Program. Readers are encouraged to read Finnegan's summary of the initial Working Model. Along with this version of the Working Model, FDA also issued two separate companion documents: the Regulatory Framework for conducting...

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No.  It can't be.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that.  Just look at our generic preemption scorecard – the proof is there.  The warnings on generic drugs must be the "same" as those on branded drugs.  Generic drug manufacturers cannot unilaterally alter, amend, or change any warning...

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Connected medical technology is rapidly transforming patient treatment. Pacemakers, insulin pumps, wearable devices that track patient activity levels and pills containing ingestible sensors that track medication adherence are among the innovations that allow physicians to monitor patients remotely, promising more cost-effective care and improved outcomes. But connected medical devices also...

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