federal_register: 2021-25612

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2021-25612 Determination of Regulatory Review Period for Purposes of Patent Extension; TRODELVY Notice The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRODELVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. 2021-11-24 2021 11 https://www.federalregister.gov/documents/2021/11/24/2021-25612/determination-of-regulatory-review-period-for-purposes-of-patent-extension-trodelvy https://www.govinfo.gov/content/pkg/FR-2021-11-24/pdf/2021-25612.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 TRODELVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an...

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