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Determination of Regulatory Review Period for Purposes of Patent Extension; XOLREMDI
Federal Register · Notice · Jun 16, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 15, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 25311Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; LIVDELZI
Federal Register · Notice · Jul 2, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 29, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 29015Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; AGAMREE
Federal Register · Notice · Jun 25, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 22, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 27027Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY
Federal Register · Notice · Feb 6, 2026
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 5, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
91 FR 5494Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; REZDIFFRA
Federal Register · Notice · Jan 27, 2026
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 27, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
91 FR 3507Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; EXBLIFEP
Federal Register · Notice · Jan 27, 2026
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 27, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
91 FR 3518Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; MIPLYFFA
Federal Register · Notice · Sep 29, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 30, 2026. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 46600Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO
Federal Register · Notice · May 12, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 20171Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; OMLONTI
Federal Register · Notice · Sep 25, 2024
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 24, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 78306Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; FRUZAQLA
Federal Register · Notice · Sep 25, 2024
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 24, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 78307Health and Human Services DepartmentFood and Drug Administration
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period
Federal Register · Notice · Nov 22, 2021
ACTION: Proposed order; extension of comment period. … On November 2, 2021, the Agency received a request to extend this comment period by a minimum of 45 days, conveying concern that the original comment period did not provide sufficient time for review of
86 FR 66318Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; ADVANTAME
Federal Register · Notice · Nov 30, 2017
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 29, 2018. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
82 FR 56828Health and Human Services DepartmentFood and Drug Administration
Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
Federal Register · Notice · Oct 4, 2018
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for a 30-day extension of the comment period.
83 FR 50109Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT
Federal Register · Notice · Jun 17, 2016
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period.
81 FR 39648Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPZELCA
Federal Register · Notice · Nov 30, 2021
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 31, 2022. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
86 FR 67960Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; MONJUVI
Federal Register · Notice · Jul 6, 2022
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 3, 2023. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
87 FR 40251Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEXXA
Federal Register · Notice · Dec 5, 2019
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 2, 2020. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
84 FR 66671Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; SHINGRIX
Federal Register · Notice · Sep 6, 2019
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 4, 2020. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
84 FR 46953Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; BRINEURA
Federal Register · Notice · Oct 17, 2018
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 15, 2019. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 52483Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; TREMFYA
Federal Register · Notice · Oct 17, 2018
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 15, 2019. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
83 FR 52471Health and Human Services DepartmentFood and Drug Administration

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