BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Docket Clock//docket-clock.pages.dev//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:FDA Vaccines / biologics deadlines (Docket Clock) X-PUBLISHED-TTL:PT12H REFRESH-INTERVAL;VALUE=DURATION:PT12H BEGIN:VEVENT UID:2026-18333-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261109 DTEND;VALUE=DATE:20261110 SUMMARY:FDA comments close: Agency Information Collection Activities\; Pro posed Collection\; Comment Request\; Human Cells\, Tissues\, and Cellular and Tissue-Based Products DESCRIPTION:Notice. Federal Register 2026-18333. Docket FDA-2026-N-9638. D etails: https://docket-clock.pages.dev/doc/2026-18333/ Official: https:// www.federalregister.gov/documents/2026/09/09/2026-18333/agency-informatio n-collection-activities-proposed-collection-comment-request-human-cells-t issues-and URL:https://www.federalregister.gov/documents/2026/09/09/2026-18333/agency -information-collection-activities-proposed-collection-comment-request-hu man-cells-tissues-and TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-20768-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261109 DTEND;VALUE=DATE:20261110 SUMMARY:FDA comments close: Agency Information Collection Activities\; Sub mission for Office of Management and Budget Review\; Comment Request\; Bi ologics License Applications\, Procedures and Requirements DESCRIPTION:Notice. Federal Register 2026-20768. Docket FDA-2026-N-6667. D etails: https://docket-clock.pages.dev/doc/2026-20768/ Official: https:// www.federalregister.gov/documents/2026/10/09/2026-20768/agency-informatio n-collection-activities-submission-for-office-of-management-and-budget-re view URL:https://www.federalregister.gov/documents/2026/10/09/2026-20768/agency -information-collection-activities-submission-for-office-of-management-an d-budget-review TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19563-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261109 DTEND;VALUE=DATE:20261110 SUMMARY:FDA comments close: Improving Patient Access to Deceased Donor Isl et Cells and Cell Products\; Request for Information DESCRIPTION:Notice. Federal Register 2026-19563. Docket FDA-2026-N-10738. Details: https://docket-clock.pages.dev/doc/2026-19563/ Official: https:/ /www.federalregister.gov/documents/2026/09/24/2026-19563/improving-patien t-access-to-deceased-donor-islet-cells-and-cell-products-request-for-info rmation URL:https://www.federalregister.gov/documents/2026/09/24/2026-19563/improv ing-patient-access-to-deceased-donor-islet-cells-and-cell-products-reques t-for-information TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19166-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261117 DTEND;VALUE=DATE:20261118 SUMMARY:FDA comments close: Biosimilar User Fee Act III Future Needs in th e Development of Interchangeable Products Post-Workshop\; Draft Strategy Document DESCRIPTION:Notice. Federal Register 2026-19166. Docket FDA-2025-N-2787. D etails: https://docket-clock.pages.dev/doc/2026-19166/ Official: https:// www.federalregister.gov/documents/2026/09/18/2026-19166/biosimilar-user-f ee-act-iii-future-needs-in-the-development-of-interchangeable-products URL:https://www.federalregister.gov/documents/2026/09/18/2026-19166/biosim ilar-user-fee-act-iii-future-needs-in-the-development-of-interchangeable- products TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19181-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261117 DTEND;VALUE=DATE:20261118 SUMMARY:FDA comments close: Electronic Submission Template for Medical Dev ice Premarket Approval Applications (PMAs)\; Draft Guidance for Industry and Food and Drug Administration Staff\; Availability DESCRIPTION:Notice. Federal Register 2026-19181. Docket FDA-2026-D-9429. D etails: https://docket-clock.pages.dev/doc/2026-19181/ Official: https:// www.federalregister.gov/documents/2026/09/18/2026-19181/electronic-submis sion-template-for-medical-device-premarket-approval-applications-pmas-dra ft URL:https://www.federalregister.gov/documents/2026/09/18/2026-19181/electr onic-submission-template-for-medical-device-premarket-approval-applicatio ns-pmas-draft TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-16960-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261118 DTEND;VALUE=DATE:20261119 SUMMARY:FDA comments close: Potency Assessment of Active Immunotherapy Pro ducts\; Draft Guidance for Industry\; Availability DESCRIPTION:Notice. Federal Register 2026-16960. Docket FDA-2026-D-8561. D etails: https://docket-clock.pages.dev/doc/2026-16960/ Official: https:// www.federalregister.gov/documents/2026/08/20/2026-16960/potency-assessmen t-of-active-immunotherapy-products-draft-guidance-for-industry-availabili ty URL:https://www.federalregister.gov/documents/2026/08/20/2026-16960/potenc y-assessment-of-active-immunotherapy-products-draft-guidance-for-industry -availability TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19660-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261125 DTEND;VALUE=DATE:20261126 SUMMARY:FDA comments close: Reauthorization of the Biosimilar User Fee Act \; Public Meeting\; Request for Comments DESCRIPTION:Notice. Federal Register 2026-19660. Docket FDA-2015-N-3326. D etails: https://docket-clock.pages.dev/doc/2026-19660/ Official: https:// www.federalregister.gov/documents/2026/09/25/2026-19660/reauthorization-o f-the-biosimilar-user-fee-act-public-meeting-request-for-comments URL:https://www.federalregister.gov/documents/2026/09/25/2026-19660/reauth orization-of-the-biosimilar-user-fee-act-public-meeting-request-for-comme nts TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-17961-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261201 DTEND;VALUE=DATE:20261202 SUMMARY:FDA comments close: Pharmacokinetics in Patients With Impaired Hep atic Function: Study Design\, Data Analysis\, and Impact on Dosage\; Draf t Guidance for Industry\; Availability DESCRIPTION:Notice. Federal Register 2026-17961. Docket FDA-2026-D-8693. D etails: https://docket-clock.pages.dev/doc/2026-17961/ Official: https:// www.federalregister.gov/documents/2026/09/02/2026-17961/pharmacokinetics- in-patients-with-impaired-hepatic-function-study-design-data-analysis-and -impact-on URL:https://www.federalregister.gov/documents/2026/09/02/2026-17961/pharma cokinetics-in-patients-with-impaired-hepatic-function-study-design-data-a nalysis-and-impact-on TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19349-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261207 DTEND;VALUE=DATE:20261208 SUMMARY:FDA comments close: Nonclinical Testing Terminology DESCRIPTION:Proposed Rule. Federal Register 2026-19349. Docket FDA-2026-N- 5347. Details: https://docket-clock.pages.dev/doc/2026-19349/ Official: h ttps://www.federalregister.gov/documents/2026/09/22/2026-19349/nonclinica l-testing-terminology URL:https://www.federalregister.gov/documents/2026/09/22/2026-19349/noncli nical-testing-terminology TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19350-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261207 DTEND;VALUE=DATE:20261208 SUMMARY:FDA comments close: Nonclinical Testing Terminology DESCRIPTION:Rule. Federal Register 2026-19350. Docket FDA-2026-N-5347. Det ails: https://docket-clock.pages.dev/doc/2026-19350/ Official: https://ww w.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing -terminology URL:https://www.federalregister.gov/documents/2026/09/22/2026-19350/noncli nical-testing-terminology TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-18300-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20270308 DTEND;VALUE=DATE:20270309 SUMMARY:FDA comments close: Determination of Regulatory Review Period for Purposes of Patent Extension\; ANDEMBRY DESCRIPTION:Notice. Federal Register 2026-18300. Docket FDA-2025-E-3595\, FDA-2025-E-3596. Details: https://docket-clock.pages.dev/doc/2026-18300/ Official: https://www.federalregister.gov/documents/2026/09/09/2026-18300 /determination-of-regulatory-review-period-for-purposes-of-patent-extensi on-andembry URL:https://www.federalregister.gov/documents/2026/09/09/2026-18300/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-ande mbry TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-18297-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20270308 DTEND;VALUE=DATE:20270309 SUMMARY:FDA comments close: Determination of Regulatory Review Period for Purposes of Patent Extension\; ANKTIVA DESCRIPTION:Notice. Federal Register 2026-18297. Docket FDA-2024-E-4125\, FDA-2024-E-4128\, FDA-2024-E-4129\, FDA-2024-E-4130\, FDA-2024-E-4131. De tails: https://docket-clock.pages.dev/doc/2026-18297/ Official: https://w ww.federalregister.gov/documents/2026/09/09/2026-18297/determination-of-r egulatory-review-period-for-purposes-of-patent-extension-anktiva URL:https://www.federalregister.gov/documents/2026/09/09/2026-18297/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-ankt iva TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19350-eff@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20270204 DTEND;VALUE=DATE:20270205 SUMMARY:FDA effective: Nonclinical Testing Terminology DESCRIPTION:Rule. Federal Register 2026-19350. Docket FDA-2026-N-5347. Det ails: https://docket-clock.pages.dev/doc/2026-19350/ Official: https://ww w.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing -terminology URL:https://www.federalregister.gov/documents/2026/09/22/2026-19350/noncli nical-testing-terminology TRANSP:TRANSPARENT END:VEVENT END:VCALENDAR