federal_register: 2023-27004

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2023-27004 Determination of Regulatory Review Period for Purposes of Patent Extension; EXKIVITY Notice The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXKIVITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product. 2023-12-08 2023 12 https://www.federalregister.gov/documents/2023/12/08/2023-27004/determination-of-regulatory-review-period-for-purposes-of-patent-extension-exkivity https://www.govinfo.gov/content/pkg/FR-2023-12-08/pdf/2023-27004.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXKIVITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of...

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