Should FDA Have More Say Over Patent Listings in the Orange Book - Lachman Blog

Should FDA Have More Say Over Patent Listings in the Orange Book?

This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the […]

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Good News and Bad News re FTC’s Action on Patent Listings

On November 7, 2023, a press release from the FTC announced that “the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” […]

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FDA 2024 Budget Proposal Proposes Fix to the “Skinny” Label Issue

The FDA released its proposed budget and legislative proposals for FY 2024 (summary can be found here).  Besides certain requests for additional funding, reauthorization of the user fee programs for new and abbreviated animal drug programs, a host of safety issues, as well as new record retention requirements to fight data integrity problems in applications and […]

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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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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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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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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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