BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Docket Clock//docket-clock.pages.dev//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:FDA Other FDA topics deadlines (Docket Clock) X-PUBLISHED-TTL:PT12H REFRESH-INTERVAL;VALUE=DURATION:PT12H BEGIN:VEVENT UID:2026-16353-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261017 DTEND;VALUE=DATE:20261018 SUMMARY:FDA comments close: Reauthorization of the Generic Drug User Fee A mendments\; Public Meeting\; Request for Comments DESCRIPTION:Notice. Federal Register 2026-16353. Docket FDA-2025-N-0873. D etails: https://docket-clock.pages.dev/doc/2026-16353/ Official: https:// www.federalregister.gov/documents/2026/08/11/2026-16353/reauthorization-o f-the-generic-drug-user-fee-amendments-public-meeting-request-for-comment s URL:https://www.federalregister.gov/documents/2026/08/11/2026-16353/reauth orization-of-the-generic-drug-user-fee-amendments-public-meeting-request- for-comments TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-16837-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261019 DTEND;VALUE=DATE:20261020 SUMMARY:FDA comments close: Determining Whether To Submit an ANDA or a 505 (b)(2) Application\; Draft Guidance for Industry\; Availability DESCRIPTION:Notice. Federal Register 2026-16837. Docket FDA-2017-D-5974. D etails: https://docket-clock.pages.dev/doc/2026-16837/ Official: https:// www.federalregister.gov/documents/2026/08/18/2026-16837/determining-wheth er-to-submit-an-anda-or-a-505b2-application-draft-guidance-for-industry URL:https://www.federalregister.gov/documents/2026/08/18/2026-16837/determ ining-whether-to-submit-an-anda-or-a-505b2-application-draft-guidance-for -industry TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19284-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261021 DTEND;VALUE=DATE:20261022 SUMMARY:FDA comments close: Agency Information Collection Activities\; Sub mission for Office of Management and Budget Review\; Comment Request\; Or phan Drugs DESCRIPTION:Notice. Federal Register 2026-19284. Docket FDA-2026-N-3400. D etails: https://docket-clock.pages.dev/doc/2026-19284/ Official: https:// www.federalregister.gov/documents/2026/09/21/2026-19284/agency-informatio n-collection-activities-submission-for-office-of-management-and-budget-re view URL:https://www.federalregister.gov/documents/2026/09/21/2026-19284/agency -information-collection-activities-submission-for-office-of-management-an d-budget-review TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-17598-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261027 DTEND;VALUE=DATE:20261028 SUMMARY:FDA comments close: Agency Information Collection Activities\; Pro posed Collection\; Comment Request\; Focus Groups and Interviews as Used by the Food and Drug Administration DESCRIPTION:Notice. Federal Register 2026-17598. Docket FDA-2026-N-8087. D etails: https://docket-clock.pages.dev/doc/2026-17598/ Official: https:// www.federalregister.gov/documents/2026/08/28/2026-17598/agency-informatio n-collection-activities-proposed-collection-comment-request-focus-groups- and URL:https://www.federalregister.gov/documents/2026/08/28/2026-17598/agency -information-collection-activities-proposed-collection-comment-request-fo cus-groups-and TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-17605-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261027 DTEND;VALUE=DATE:20261028 SUMMARY:FDA comments close: Agency Information Collection Activities\; Pro posed Collection\; Comment Request\; Qualitative Feedback on Agency Servi ce Delivery DESCRIPTION:Notice. Federal Register 2026-17605. Docket FDA-2026-N-8898. D etails: https://docket-clock.pages.dev/doc/2026-17605/ Official: https:// www.federalregister.gov/documents/2026/08/28/2026-17605/agency-informatio n-collection-activities-proposed-collection-comment-request-qualitative-f eedback-on URL:https://www.federalregister.gov/documents/2026/08/28/2026-17605/agency -information-collection-activities-proposed-collection-comment-request-qu alitative-feedback-on TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-20085-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261102 DTEND;VALUE=DATE:20261103 SUMMARY:FDA comments close: Agency Information Collection Activities\; Sub mission for Office of Management and Budget Review\; Comment Request\; Vo luntary Improvement Program DESCRIPTION:Notice. Federal Register 2026-20085. Docket FDA-2026-N-6876. D etails: https://docket-clock.pages.dev/doc/2026-20085/ Official: https:// www.federalregister.gov/documents/2026/10/01/2026-20085/agency-informatio n-collection-activities-submission-for-office-of-management-and-budget-re view URL:https://www.federalregister.gov/documents/2026/10/01/2026-20085/agency -information-collection-activities-submission-for-office-of-management-an d-budget-review TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-18133-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261103 DTEND;VALUE=DATE:20261104 SUMMARY:FDA comments close: Advancing Development of Botanical Drug Produc ts\; Request for Information DESCRIPTION:Notice. Federal Register 2026-18133. Docket FDA-2026-N-9550. D etails: https://docket-clock.pages.dev/doc/2026-18133/ Official: https:// www.federalregister.gov/documents/2026/09/04/2026-18133/advancing-develop ment-of-botanical-drug-products-request-for-information URL:https://www.federalregister.gov/documents/2026/09/04/2026-18133/advanc ing-development-of-botanical-drug-products-request-for-information TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-15887-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261103 DTEND;VALUE=DATE:20261104 SUMMARY:FDA comments close: Establishment of a Quantitative Medicine Innov ation Network: Scope\, Feasibility\, and Opportunities\; Request for Info rmation DESCRIPTION:Notice. Federal Register 2026-15887. Docket FDA-2026-N-7605. D etails: https://docket-clock.pages.dev/doc/2026-15887/ Official: https:// www.federalregister.gov/documents/2026/08/05/2026-15887/establishment-of- a-quantitative-medicine-innovation-network-scope-feasibility-and-opportun ities URL:https://www.federalregister.gov/documents/2026/08/05/2026-15887/establ ishment-of-a-quantitative-medicine-innovation-network-scope-feasibility-a nd-opportunities TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-18299-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\; Pregnancy Exposure Registry Enrollme nt Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications DESCRIPTION:Notice. Federal Register 2026-18299. Docket FDA-2026-N-8361. D etails: https://docket-clock.pages.dev/doc/2026-18299/ Official: https:// www.federalregister.gov/documents/2026/09/09/2026-18299/agency-informatio n-collection-activities-proposed-collection-comment-request-pregnancy-exp osure URL:https://www.federalregister.gov/documents/2026/09/09/2026-18299/agency -information-collection-activities-proposed-collection-comment-request-pr egnancy-exposure TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-20765-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\; Ex panded Access to Investigational Drugs for Treatment Use DESCRIPTION:Notice. Federal Register 2026-20765. Docket FDA-2026-N-7426. D etails: https://docket-clock.pages.dev/doc/2026-20765/ Official: https:// www.federalregister.gov/documents/2026/10/09/2026-20765/agency-informatio n-collection-activities-submission-for-office-of-management-and-budget-re view URL:https://www.federalregister.gov/documents/2026/10/09/2026-20765/agency -information-collection-activities-submission-for-office-of-management-an d-budget-review TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-20990-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261113 DTEND;VALUE=DATE:20261114 SUMMARY:FDA comments close: Agency Information Collection Activities\; Sub mission for Office of Management and Budget Review\; Comment Request\; Re quirements for Cosmetic Products DESCRIPTION:Notice. Federal Register 2026-20990. Docket FDA-2026-N-6739. D etails: https://docket-clock.pages.dev/doc/2026-20990/ Official: https:// www.federalregister.gov/documents/2026/10/14/2026-20990/agency-informatio n-collection-activities-submission-for-office-of-management-and-budget-re view URL:https://www.federalregister.gov/documents/2026/10/14/2026-20990/agency -information-collection-activities-submission-for-office-of-management-an d-budget-review TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19141-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261117 DTEND;VALUE=DATE:20261118 SUMMARY:FDA comments close: Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products\; Draft Guidance for Industry\; Availabilit y DESCRIPTION:Notice. Federal Register 2026-19141. Docket FDA-2026-D-7233. D etails: https://docket-clock.pages.dev/doc/2026-19141/ Official: https:// www.federalregister.gov/documents/2026/09/18/2026-19141/target-animal-saf ety-evaluation-for-veterinary-monoclonal-antibody-products-draft-guidance -for URL:https://www.federalregister.gov/documents/2026/09/18/2026-19141/target -animal-safety-evaluation-for-veterinary-monoclonal-antibody-products-dra ft-guidance-for TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19282-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261120 DTEND;VALUE=DATE:20261121 SUMMARY:FDA comments close: Agency Information Collection Activities\; Pro posed Collection\; Comment Request\; State Petitions for Exemption From P reemption DESCRIPTION:Notice. Federal Register 2026-19282. Docket FDA-2026-N-10430. Details: https://docket-clock.pages.dev/doc/2026-19282/ Official: https:/ /www.federalregister.gov/documents/2026/09/21/2026-19282/agency-informati on-collection-activities-proposed-collection-comment-request-state-petiti ons-for URL:https://www.federalregister.gov/documents/2026/09/21/2026-19282/agency -information-collection-activities-proposed-collection-comment-request-st ate-petitions-for TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-19283-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261120 DTEND;VALUE=DATE:20261121 SUMMARY:FDA comments close: Agency Information Collection Activities\; Pro posed Collection\; Comment Request\; Temporary Marketing Permit Applicati ons DESCRIPTION:Notice. Federal Register 2026-19283. Docket FDA-2026-N-10363. Details: https://docket-clock.pages.dev/doc/2026-19283/ Official: https:/ /www.federalregister.gov/documents/2026/09/21/2026-19283/agency-informati on-collection-activities-proposed-collection-comment-request-temporary-ma rketing URL:https://www.federalregister.gov/documents/2026/09/21/2026-19283/agency -information-collection-activities-proposed-collection-comment-request-te mporary-marketing TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-20663-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261207 DTEND;VALUE=DATE:20261208 SUMMARY:FDA comments close: Agency Information Collection Activities\; Pro posed Collection\; Comment Request\; Channels of Trade Policy for Commodi ties With Residues of Pesticide Chemicals\, for Which Tolerances Have Bee n Revoked\, Suspended\, or Modified by the Environmental Protection Agenc y Pursuant to Dietary Risk Considerations DESCRIPTION:Notice. Federal Register 2026-20663. Docket FDA-2026-N-10605. Details: https://docket-clock.pages.dev/doc/2026-20663/ Official: https:/ /www.federalregister.gov/documents/2026/10/08/2026-20663/agency-informati on-collection-activities-proposed-collection-comment-request-channels-of- trade URL:https://www.federalregister.gov/documents/2026/10/08/2026-20663/agency -information-collection-activities-proposed-collection-comment-request-ch annels-of-trade TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-20766-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261208 DTEND;VALUE=DATE:20261209 SUMMARY:FDA comments close: Determination of Regulatory Review Period for Purposes of Patent Extension\; MONOFERRIC DESCRIPTION:Notice. Federal Register 2026-20766. Docket FDA-2020-E-1882\, FDA-2020-E-1892. Details: https://docket-clock.pages.dev/doc/2026-20766/ Official: https://www.federalregister.gov/documents/2026/10/09/2026-20766 /determination-of-regulatory-review-period-for-purposes-of-patent-extensi on-monoferric URL:https://www.federalregister.gov/documents/2026/10/09/2026-20766/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-mono ferric TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-13006-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20261228 DTEND;VALUE=DATE:20261229 SUMMARY:FDA comments close: Determination of Regulatory Review Period for Purposes of Patent Extension\; VYALEV DESCRIPTION:Notice. Federal Register 2026-13006. Docket FDA-2025-E-0162\, FDA-2025-E-0163\, FDA-2025-E-0164. Details: https://docket-clock.pages.de v/doc/2026-13006/ Official: https://www.federalregister.gov/documents/202 6/06/29/2026-13006/determination-of-regulatory-review-period-for-purposes -of-patent-extension-vyalev URL:https://www.federalregister.gov/documents/2026/06/29/2026-13006/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-vyal ev TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-16247-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20270208 DTEND;VALUE=DATE:20270209 SUMMARY:FDA comments close: Determination of Regulatory Review Period for Purposes of Patent Extension\; BRINSUPRI DESCRIPTION:Notice. Federal Register 2026-16247. Docket FDA-2025-E-5206. D etails: https://docket-clock.pages.dev/doc/2026-16247/ Official: https:// www.federalregister.gov/documents/2026/08/10/2026-16247/determination-of- regulatory-review-period-for-purposes-of-patent-extension-brinsupri URL:https://www.federalregister.gov/documents/2026/08/10/2026-16247/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-brin supri TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-16246-close@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20270208 DTEND;VALUE=DATE:20270209 SUMMARY:FDA comments close: Determination of Regulatory Review Period for Purposes of Patent Extension\; DAYVIGO DESCRIPTION:Notice. Federal Register 2026-16246. Docket FDA-2025-E-0707. D etails: https://docket-clock.pages.dev/doc/2026-16246/ Official: https:// www.federalregister.gov/documents/2026/08/10/2026-16246/determination-of- regulatory-review-period-for-purposes-of-patent-extension-dayvigo URL:https://www.federalregister.gov/documents/2026/08/10/2026-16246/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-dayv igo TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-18298-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\; ANZUPGO DESCRIPTION:Notice. Federal Register 2026-18298. Docket FDA-2025-E-3939. D etails: https://docket-clock.pages.dev/doc/2026-18298/ Official: https:// www.federalregister.gov/documents/2026/09/09/2026-18298/determination-of- regulatory-review-period-for-purposes-of-patent-extension-anzupgo URL:https://www.federalregister.gov/documents/2026/09/09/2026-18298/determ ination-of-regulatory-review-period-for-purposes-of-patent-extension-anzu pgo TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-15339-eff@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20270930 DTEND;VALUE=DATE:20271001 SUMMARY:FDA effective: Animal Drug User Fee Rates and Payment Procedures f or Fiscal Year 2027 DESCRIPTION:Notice. Federal Register 2026-15339. Docket FDA-2026-N-7558. D etails: https://docket-clock.pages.dev/doc/2026-15339/ Official: https:// www.federalregister.gov/documents/2026/07/30/2026-15339/animal-drug-user- fee-rates-and-payment-procedures-for-fiscal-year-2027 URL:https://www.federalregister.gov/documents/2026/07/30/2026-15339/animal -drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2027 TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-04368-eff@docket-clock.pages.dev DTSTAMP:20261017T145145Z DTSTART;VALUE=DATE:20330307 DTEND;VALUE=DATE:20330308 SUMMARY:FDA effective: Revising the National Drug Code Format and Drug Lab el Barcode Requirements DESCRIPTION:Rule. Federal Register 2026-04368. Docket FDA-2021-N-1351. Det ails: https://docket-clock.pages.dev/doc/2026-04368/ Official: https://ww w.federalregister.gov/documents/2026/03/05/2026-04368/revising-the-nation al-drug-code-format-and-drug-label-barcode-requirements URL:https://www.federalregister.gov/documents/2026/03/05/2026-04368/revisi ng-the-national-drug-code-format-and-drug-label-barcode-requirements TRANSP:TRANSPARENT END:VEVENT END:VCALENDAR