CDER Letter to USPTO Regarding Patent Matter, Apr 22
Summary
The FDA Center for Drug Evaluation and Research (CDER) issued a letter to the United States Patent and Trademark Office (USPTO) on April 22, 2024, transmitted via regulations.gov docket FDA-2024-E-3578. The document is currently hosted on regulations.gov with the underlying letter available as an attachment (attachment_1.pdf). The full content of the letter is not accessible through the regulations.gov viewer; the document metadata identifies CDER as the authoring component. No substantive regulatory obligations, deadlines, or penalties are described in the available source text.
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GovPing monitors Regs.gov: Food and Drug Administration for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 379 changes logged to date.
What changed
CDER issued an inter-agency correspondence letter to the USPTO, dated April 22, 2024, filed under docket FDA-2024-E-3578. The document is available as a PDF attachment on regulations.gov, though the regulations.gov viewer does not display the letter's contents directly. This appears to be routine CDER engagement with USPTO in connection with a patent matter, likely related to drug approval or patent term considerations. Affected parties with interests in the referenced patent proceedings may wish to obtain the attachment directly from regulations.gov to review the substantive content.
Pharmaceutical companies, patent applicants, and their legal representatives involved in proceedings before both FDA and USPTO should monitor the docket for the full letter. This type of inter-agency correspondence may signal FDA's technical assessment or positions relevant to patentability, Orange Book listings, or patent term restoration matters.
Archived snapshot
Apr 23, 2026GovPing 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.
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Attachments 1
Letter to U. S. Patent and Trademark Office
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- Author(s) CDER
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