federal_register: 2021-24435

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2021-24435 Determination of Regulatory Review Period for Purposes of Patent Extension; DOJOLVI Notice The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DOJOLVI 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 claim that human drug product. 2021-11-09 2021 11 https://www.federalregister.gov/documents/2021/11/09/2021-24435/determination-of-regulatory-review-period-for-purposes-of-patent-extension-dojolvi https://www.govinfo.gov/content/pkg/FR-2021-11-09/pdf/2021-24435.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 DOJOLVI 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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