Amendment ID: S2397-9

Amendment 9

Early Notice

Mr. Boncore moves that the proposed new draft be amended by striking lines 162 through 166 and inserting in place thereof the following:-- 

Early notice for a pipeline drug under this subsection shall be  submitted to the commission in writing not later than 60 days after receipt of the federal Food  and Drug Administration action date.  Early notice for a biosimilar drug or generic drug under this subsection shall be submitted to the commission in writing not later than 3 business days after the biosimilar drug or generic drug’s effective date of distribution.