505(b)(2) Archives - Lachman Consultant Services, Inc.

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

By Bob Pollock May 07, 2024 505(b)(2) ANDAs Applications FDA Generics Labeling Regulatory Affairs

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 […]

Nov

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

By Bob Pollock Nov 14, 2023 505(b)(2) ANDAs Generics Improper Patent Listing

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,” […]

Mar

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

By Bob Pollock Mar 10, 2023 505(b)(2) FDA Generics Regulatory Affairs Skinny Labeling

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 […]

Sep

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

By Bob Pollock Sep 23, 2022 505(b)(2) Applications Regulatory Affairs Therapeutic equivalence

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 […]

Apr

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

By Bob Pollock Apr 11, 2022 505(b)(2) FDA NDA Therapeutic equivalence ratings

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 […]

Jun

Process MaPP for Conversion of Approved ANDA to TA after Finding of Patent Infringement

By Bob Pollock Jun 11, 2020 505(b)(2) ANDAs FDA Generics NDA Regulatory Affairs

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 […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

Sep

Revised 505(q) Petition Guidance Published

By Bob Pollock Sep 18, 2019 505(b)(2) ANDAs BLA FDA Generics Regulatory Affairs

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 […]