505(b)(2)

23
Sep

Feedback from Industry on July 2022 Guidance Regarding TE Ratings for 505(b)(2) Products

I read a great article by Joanne S. Egolvitch in the RAPS Regulatory News this morning about elimination of Citizen Petitions for TE ratings for 505(b)(2) products (here).  The issue centers on the FDA’s (kind of wonky) requirement that 505(b)(2) applications with minor formulation changes requiring them to be submitted as an NDA also require […]

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11
Apr

The Hunt for the Elusive TE Rating for Certain 505(b)(2) Applications – So What’s Holding Up the FDA?

The 505(b)(2) application is really a hybrid of a New Drug Application (NDA) approved under Section 505C of the FFDCA  Act (the Act) and an Abbreviated New Drug Application (ANDA) which is approved under Section 505(j) of the Act.  The (b)(2) pathway was a creation born out of the Hatch-Waxman Act of 1984. It permits […]

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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This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in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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