Law

We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" rule) it proposed two years ago in order to overturn Supreme Court precedent recognizing preemption in generic drug product liability litigation.  The new date is apparently July, 2016.  We looked briefly on the FDA's website, but couldn't find anything about this, but given the interest, it seemed important enough to pass along.

This is starting to look like the FDA is playing out the string.  With this date, there doesn't seem any way that the rule becomes effective during this administration, given the time that expected legal challenges would take.

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Posted By Bexis to Drug and Device Law at 12/04/2015 07:55:00 AM

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