505(b)(2)

11
Jun

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 […]

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18
Sep
Petition Guidance Published Image

Revised 505(q) Petition Guidance Published

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that […]

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