Changeflow GovPing Healthcare & Life Sciences Letter from FDA CDER to USPTO, Apr 15
Routine Notice Added Final

Letter from FDA CDER to USPTO, Apr 15

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Summary

FDA CDER issued correspondence to the USPTO containing two PDF attachments. The primary document body states no documents are available to view or download directly. The attachments appear to be inter-agency communications related to a patent matter filed under docket FDA-2024-E-3588. This type of correspondence typically addresses patent term extension applications, patent listings, or other drug patent-related matters referred by the USPTO.

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About this source

Every FDA document on regulations.gov, the federal rulemaking portal. This is where the agency posts variances, advisory committee meeting notices, draft guidance for comment, citizen petition responses, and procedural rules that do not get a separate Federal Register slot. Around 240 a month. FDA's heavy regulations.gov use means tracking only the Federal Register misses a meaningful chunk of what the agency does day-to-day. Watch this if you manufacture devices, submit IND or NDA applications, run a lab, or advise sponsors on FDA process. GovPing publishes each posting with the docket, document type, division (CDER, CDRH, CFSAN), and comment window where one applies.

What changed

FDA CDER transmitted correspondence to the USPTO with two attachments available for download. The main document body indicates no documents are viewable in the web interface, with content accessible only through the linked PDF attachments. The docket reference FDA-2024-E-3588 suggests this relates to a Patent Term Extension or listed patent matter.

Affected parties with interests in the referenced patent matter should review the attached correspondence directly. Patent holders, pharmaceutical companies, and their legal representatives involved in FDA-USPTO inter-agency proceedings should monitor related docket filings for complete documentation.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Content

There are no documents available to view or download

Attachments 2

Letter from FDA CDER to U.S. Patent and Trademark Office - April 15, 2026

More Information
- Author(s) CDER
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Letter from FDA CDER to U.S. Patent and Trademark Office

More Information
- Author(s) CDER
Download

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Last updated

Classification

Agency
FDA
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
FDA-2024-E-3588

Who this affects

Applies to
Pharmaceutical companies Manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Patent extension review Inter-agency correspondence
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Regulatory Affairs
Topics
Pharmaceuticals

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