Drugs

Draft Guidance Clarifies Orange Book Patent Submission Forms

FDA has released a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book, providing answers to common questions surrounding the use of Forms FDA 3542 and FDA 3542a. The draft, “Forms FDA 3542a and FDA 3542: Questions and Answers”, is intended to clarify when each form should be used, who may complete and sign them, submission timelines, and FDA's expectations for correcting or updating patent information.

The guidance focuses on patent information submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, which forms the basis for Orange Book patent listings that are central to Hatch-Waxman patent litigation and generic drug approval pathways. FDA says NDA applicants must use Form FDA 3542a when submitting patent information for unapproved applications, amendments, or supplements, while NDA holders must use Form FDA 3542 to submit patent information for approved products and supplements.

Among the key clarifications, FDA emphasizes that only patents claiming the drug substance, drug product, or approved methods of use associated with the NDA should be submitted. For method-of-use patents, sponsors must identify the specific approved use covered by the patent and provide an appropriate use code for Orange Book publication.

The agency also reiterates statutory filing deadlines. Patent information for approved NDAs generally must be submitted within 30 days of approval, while patents issued after approval must be submitted within 30 days of patent issuance. If FDA identifies deficiencies in a timely filed submission, sponsors have 15 days to provide corrected information.

FDA further clarifies that patent owners who are not NDA holders may assist in preparing and signing the forms but cannot submit them directly to the agency. Only NDA applicants or NDA holders may file the forms with FDA. The guidance also states that a separate form must be submitted for each patent.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome