
Process MaPP for Conversion of Approved ANDA to TA after Finding of Patent Infringement
Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA). The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]