documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
- perpetual_docket
- 1 = a standing/perpetual docket carrying a sentinel comment-end date (2050 or later; in practice 2099/2100 — agency guidance and exemption dockets that never close). 0 = an ordinary docket with a real deadline. NULL = no end date reported. The site's Open-for-Comment surface EXCLUDES perpetual_docket = 1 by default, so the site count and the bulk dump answer the same question differently: the dump is complete and includes them.
- comment_end_date
- The comment deadline as an Eastern (America/New_York) calendar date — CORRECTED in the 2026-09-06 daily snapshot (DataDawn queue #498): a snapshot whose _metadata row comment_end_date_grain reads 'eastern' carries the Eastern date; the pre-correction snapshots (through 2026-09-05) held the UTC-rolled day, one day LATE on every end-of-day close. Federal comment periods close at 11:59:59 PM Eastern and the source publishes that instant in UTC ('2026-08-26T03:59:59Z' = the 2026-08-25 deadline). Prefer comment_end_datetime for any arithmetic and convert it to America/New_York yourself; never 'subtract a day' from this column.
- comment_end_datetime
- AUTHORITATIVE. The full UTC instant of the comment deadline ('2026-08-26 03:59:59' == 11:59:59 PM Eastern on 2026-08-25). Convert to America/New_York for the official date; prefer this column over comment_end_date for anything computed.
143 rows where agency_id = "FDA" sorted by comment_end_datetime descending
This data as json, CSV (advanced)
agency_id 1
- FDA · 143 ✖
| id | agency_id | docket_id | title | document_type | subtype | posted_date | posted_year | posted_month | comment_start_date | comment_end_date | comment_end_datetime ▲ | perpetual_docket | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2015-N-3469-0001 | FDA | FDA-2015-N-3469 | Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | Notice | Notice of Availability | 2015-10-27 | 2015 | 10 | 2015-10-27 | 2050-02-21 | 2050-02-22 04:59:59 | 1 | 2026-08-11 09:00:50 | 2015-27270 | 1 | 0 | 0900006481cf17b1 |
| FDA-2015-N-3534-0001 | FDA | FDA-2015-N-3534 | Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | Notice | Notice of Availability | 2015-10-27 | 2015 | 10 | 2015-10-27 | 2050-02-21 | 2050-02-22 04:59:59 | 1 | 2026-09-20 09:00:16 | 2015-27271 | 1 | 0 | 0900006481cf1710 |
| FDA-2011-N-0655-0041 | FDA | FDA-2011-N-0655 | Animal Generic Drug User Fee Act; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-04-17 | 2026 | 4 | 2026-04-17 | 2027-12-01 | 2027-12-02 04:59:59 | 0 | 2026-07-01 09:00:24 | 2026-07497 | 1 | 0 | 09000064b928930a |
| FDA-2011-N-0656-1315 | FDA | FDA-2011-N-0656 | Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate | Notice | General Notice | 2026-05-11 | 2026 | 5 | 2026-05-11 | 2027-12-01 | 2027-12-02 04:59:59 | 0 | 2026-08-13 14:40:33 | 2026-09283 | 1 | 0 | 09000064b92cacd0 |
| FDA-2011-N-0655-0042 | FDA | FDA-2011-N-0655 | Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intent To Participate | Notice | Notice of Intent | 2026-05-11 | 2026 | 5 | 2026-05-11 | 2027-12-01 | 2027-12-02 04:59:59 | 0 | 2026-08-13 14:41:39 | 2026-09284 | 1 | 0 | 09000064b92cf91b |
| FDA-2011-N-0656-1314 | FDA | FDA-2011-N-0656 | Animal Drug User Fee Act; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-04-17 | 2026 | 4 | 2026-04-17 | 2027-12-01 | 2027-12-02 04:59:59 | 0 | 2026-08-20 09:01:12 | 2026-07498 | 1 | 0 | 09000064b928948d |
| FDA-2026-N-7864-0001 | FDA | FDA-2026-N-7864 | Data Request (DR001): Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use | Other | Request | 2026-07-28 | 2026 | 7 | 2026-07-28 | 2027-01-25 | 2027-01-26 04:59:59 | 0 | 2026-07-28 16:50:16 | 1 | 0 | 09000064b93c7444 | |
| FDA-2026-N-0131-0001 | FDA | FDA-2026-N-0131 | FDA Rare Disease Innovation Hub Future Programming; Request for Comments | Notice | Request for Comments | 2026-01-30 | 2026 | 1 | 2026-01-30 | 2026-12-31 | 2027-01-01 04:59:59 | 0 | 2026-07-08 09:00:11 | 2026-01903 | 1 | 0 | 09000064b91893ee |
| FDA-2025-N-3262-0001 | FDA | FDA-2025-N-3262 | Substances Generally Recognized as Safe | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2026-08-11 | 2026 | 8 | 2026-08-11 | 2026-12-09 | 2026-12-10 04:59:59 | 0 | 2026-10-08 09:00:31 | 2026-16296 | 1 | 0 | 09000064b942ea41 |
| FDA-2026-N-5347-0001 | FDA | FDA-2026-N-5347 | Nonclinical Testing Terminology | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2026-09-22 | 2026 | 9 | 2026-09-22 | 2026-12-07 | 2026-12-08 04:59:59 | 0 | 2026-10-08 09:00:48 | 2026-19349 | 1 | 0 | 09000064b95ae769 |
| FDA-2026-N-5347-0002 | FDA | FDA-2026-N-5347 | Nonclinical Testing Terminology | Rule | Direct Final Rule | 2026-09-22 | 2026 | 9 | 2026-09-22 | 2026-12-07 | 2026-12-08 04:59:59 | 0 | 2026-10-08 09:00:48 | 2026-19350 | 1 | 0 | 09000064b95ae59d |
| FDA-2026-D-8693-0002 | FDA | FDA-2026-D-8693 | Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Guidance for Industry; Draft Guidance for Industry | Other | Guidance | 2026-09-02 | 2026 | 9 | 2026-09-02 | 2026-12-01 | 2026-12-02 04:59:59 | 0 | 2026-09-03 00:56:30 | 1 | 0 | 09000064b94bc729 | |
| FDA-2026-D-8693-0001 | FDA | FDA-2026-D-8693 | Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-09-02 | 2026 | 9 | 2026-09-02 | 2026-12-01 | 2026-12-02 04:59:59 | 0 | 2026-09-03 18:40:25 | 2026-17961 | 1 | 0 | 09000064b94bf507 |
| FDA-2026-N-10132-0001 | FDA | FDA-2026-N-10132 | Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards | Notice | 60 Day Proposed Information Collection | 2026-09-29 | 2026 | 9 | 2026-09-29 | 2026-11-30 | 2026-12-01 04:59:59 | 0 | 2026-09-29 17:15:35 | 2026-19849 | 1 | 0 | 09000064b95e7083 |
| FDA-2012-N-1021-0107 | FDA | FDA-2012-N-1021 | Instructions for Submitting Comments on the CDRH Fiscal Year 2027 Proposed Guidance Development | Other | Additional Information | 2026-10-01 | 2026 | 10 | 2026-10-01 | 2026-11-30 | 2026-12-01 04:59:59 | 0 | 2026-10-07 09:00:30 | 1 | 0 | 09000064b95fb842 | |
| FDA-2018-D-4533-2363 | FDA | FDA-2018-D-4533 | Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request | Notice | Notice of Availability | 2026-08-28 | 2026 | 8 | 2026-08-28 | 2026-11-27 | 2026-11-28 04:59:59 | 0 | 2026-08-28 16:31:49 | 2026-17580 | 1 | 0 | 09000064b94a6448 |
| FDA-2018-D-4533-2364 | FDA | FDA-2018-D-4533 | Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities; Draft Guidance | Other | Guidance | 2026-08-28 | 2026 | 8 | 2026-08-28 | 2026-11-27 | 2026-11-28 04:59:59 | 0 | 2026-10-06 09:00:30 | 1 | 0 | 09000064b94a6e26 | |
| FDA-2015-N-3326-0056 | FDA | FDA-2015-N-3326 | Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-09-25 | 2026 | 9 | 2026-09-25 | 2026-11-25 | 2026-11-26 04:59:59 | 0 | 2026-10-06 09:00:35 | 2026-19660 | 1 | 0 | 09000064b95c53b7 |
| FDA-2026-N-9505-0001 | FDA | FDA-2026-N-9505 | Robotically-Assisted Surgical Devices—Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-09-25 | 2026 | 9 | 2026-09-25 | 2026-11-24 | 2026-11-25 04:59:59 | 0 | 2026-09-25 19:21:13 | 2026-19704 | 1 | 0 | 09000064b95c549b |
| FDA-2026-P-5995-0001 | FDA | FDA-2026-P-5995 | Suitability Petition from Hyman, Phelps, & McNamara P.C. | Other | Petition(s) | 2026-05-28 | 2026 | 5 | 2026-05-28 | 2026-11-24 | 2026-11-25 04:59:59 | 0 | 2026-09-29 15:44:43 | 1 | 0 | 09000064b92f59e1 | |
| FDA-2026-N-8563-0001 | FDA | FDA-2026-N-8563 | Regulatory Science Innovations Catalyzing Medical Device Development_Co-sponsored Public Meeting | Other | Meeting | 2026-08-06 | 2026 | 8 | 2026-08-06 | 2026-11-24 | 2026-11-25 04:59:59 | 0 | 2026-10-04 09:00:15 | 1 | 0 | 09000064b940e756 | |
| FDA-2026-N-9505-0002 | FDA | FDA-2026-N-9505 | Robotically-Assisted Surgical Devices - Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Draft Guidance | Other | Guidance | 2026-09-25 | 2026 | 9 | 2026-09-25 | 2026-11-24 | 2026-11-25 04:59:59 | 0 | 2026-10-07 09:00:30 | 1 | 0 | 09000064b95c6e19 | |
| FDA-2026-N-10100-0001 | FDA | FDA-2026-N-10100 | FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics | Notice | Meeting | 2026-08-31 | 2026 | 8 | 2026-09-23 | 2026-11-22 | 2026-11-23 04:59:59 | 0 | 2026-08-31 22:10:19 | 1 | 0 | 09000064b94b538f | |
| FDA-2026-N-10363-0001 | FDA | FDA-2026-N-10363 | Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications | Notice | 60 Day Proposed Information Collection | 2026-09-21 | 2026 | 9 | 2026-09-21 | 2026-11-20 | 2026-11-21 04:59:59 | 0 | 2026-09-21 17:16:01 | 2026-19283 | 1 | 0 | 09000064b959db67 |
| FDA-2026-N-10430-0001 | FDA | FDA-2026-N-10430 | Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption | Notice | 60 Day Proposed Information Collection | 2026-09-21 | 2026 | 9 | 2026-09-21 | 2026-11-20 | 2026-11-21 04:59:59 | 0 | 2026-09-21 17:21:17 | 2026-19282 | 1 | 0 | 09000064b959db5f |
| FDA-2026-N-10033-0001 | FDA | FDA-2026-N-10033 | Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | Notice | 60 Day Proposed Information Collection | 2026-09-21 | 2026 | 9 | 2026-09-21 | 2026-11-20 | 2026-11-21 04:59:59 | 0 | 2026-09-22 09:00:47 | 2026-19281 | 1 | 0 | 09000064b959dbae |
| FDA-2026-N-10429-0001 | FDA | FDA-2026-N-10429 | Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information | Notice | Requests for Information (RFI) | 2026-10-06 | 2026 | 10 | 2026-10-06 | 2026-11-20 | 2026-11-21 04:59:59 | 0 | 2026-10-08 09:00:49 | 2026-20427 | 1 | 0 | 09000064b962e7b9 |
| FDA-2026-D-8561-0001 | FDA | FDA-2026-D-8561 | Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-08-20 | 2026 | 8 | 2026-08-20 | 2026-11-18 | 2026-11-19 04:59:59 | 0 | 2026-08-20 17:54:40 | 2026-16960 | 1 | 0 | 09000064b946c7f3 |
| FDA-2026-D-8561-0002 | FDA | FDA-2026-D-8561 | Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry | Other | Guidance | 2026-08-20 | 2026 | 8 | 2026-08-20 | 2026-11-18 | 2026-11-19 04:59:59 | 0 | 2026-08-20 17:59:44 | 1 | 0 | 09000064b946ee4d | |
| FDA-2026-D-9429-0001 | FDA | FDA-2026-D-9429 | Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2026-09-18 | 2026 | 9 | 2026-09-18 | 2026-11-17 | 2026-11-18 04:59:59 | 0 | 2026-09-18 18:00:19 | 2026-19181 | 1 | 0 | 09000064b958f5ee |
| FDA-2026-D-9429-0002 | FDA | FDA-2026-D-9429 | Electronic Submission Template for Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff - Draft Guidance | Other | Guidance | 2026-09-18 | 2026 | 9 | 2026-09-18 | 2026-11-17 | 2026-11-18 04:59:59 | 0 | 2026-09-18 18:06:45 | 1 | 0 | 09000064b95876d8 | |
| FDA-2026-D-7233-0001 | FDA | FDA-2026-D-7233 | Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-09-18 | 2026 | 9 | 2026-09-18 | 2026-11-17 | 2026-11-18 04:59:59 | 0 | 2026-09-18 18:09:09 | 2026-19141 | 1 | 0 | 09000064b958f536 |
| FDA-2025-N-2787-0007 | FDA | FDA-2025-N-2787 | Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document | Notice | Notice of Availability | 2026-09-18 | 2026 | 9 | 2026-09-18 | 2026-11-17 | 2026-11-18 04:59:59 | 0 | 2026-09-18 18:37:52 | 2026-19166 | 1 | 0 | 09000064b958ecea |
| FDA-2025-N-2787-0008 | FDA | FDA-2025-N-2787 | BsUFA III Future Needs for the Development of Interchangeable Products; Post-Workshop Strategy Document | Other | Request | 2026-09-18 | 2026 | 9 | 2026-09-18 | 2026-11-17 | 2026-11-18 04:59:59 | 0 | 2026-09-25 09:00:32 | 1 | 0 | 09000064b9592e12 | |
| FDA-2026-D-7233-0002 | FDA | FDA-2026-D-7233 | Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products VICH GL62; Guidance for Industry (GFI) #298 - Draft Guidance | Other | Guidance | 2026-09-18 | 2026 | 9 | 2026-09-18 | 2026-11-17 | 2026-11-18 04:59:59 | 0 | 2026-09-25 09:00:32 | 1 | 0 | 09000064b958e85f | |
| FDA-2026-N-10165-0001 | FDA | FDA-2026-N-10165 | Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments | Notice | Request for Comments | 2026-09-15 | 2026 | 9 | 2026-09-15 | 2026-11-13 | 2026-11-14 04:59:59 | 0 | 2026-09-16 09:00:44 | 2026-18805 | 1 | 0 | 09000064b955afbc |
| FDA-2026-N-8692-0001 | FDA | FDA-2026-N-8692 | Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Pathogen-Agnostic Sequencing | Notice | Request for Comments | 2026-09-16 | 2026 | 9 | 2026-09-16 | 2026-11-12 | 2026-11-13 04:59:59 | 0 | 2026-10-04 09:00:20 | 2026-18920 | 1 | 0 | 09000064b956b6a9 |
| FDA-2026-N-9350-0001 | FDA | FDA-2026-N-9350 | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking | Notice | 60 Day Proposed Information Collection | 2026-09-11 | 2026 | 9 | 2026-09-11 | 2026-11-10 | 2026-11-11 04:59:59 | 0 | 2026-09-30 09:00:20 | 2026-18529 | 1 | 0 | 09000064b951dd42 |
| FDA-2024-E-4125-0005 | FDA | FDA-2024-E-4125 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 17:47:05 | 2026-18297 | 1 | 0 | 09000064b9506ef3 |
| FDA-2024-E-4128-0005 | FDA | FDA-2024-E-4128 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 17:49:59 | 2026-18297 | 1 | 0 | 09000064b94cc9f8 |
| FDA-2024-E-4129-0005 | FDA | FDA-2024-E-4129 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 17:52:57 | 2026-18297 | 1 | 0 | 09000064b94cc9f9 |
| FDA-2024-E-4130-0005 | FDA | FDA-2024-E-4130 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 17:56:33 | 2026-18297 | 1 | 0 | 09000064b94cc9fa |
| FDA-2024-E-4131-0005 | FDA | FDA-2024-E-4131 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 18:01:24 | 2026-18297 | 1 | 0 | 09000064b94cc9fb |
| FDA-2025-E-3595-0005 | FDA | FDA-2025-E-3595 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 18:09:30 | 2026-18300 | 1 | 0 | 09000064b9506ef2 |
| FDA-2025-E-3596-0005 | FDA | FDA-2025-E-3596 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 18:12:58 | 2026-18300 | 1 | 0 | 09000064b94cc9fc |
| FDA-2025-E-3939-0005 | FDA | FDA-2025-E-3939 | Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO | Notice | Determinations | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-09 18:26:41 | 2026-18298 | 1 | 0 | 09000064b9506dda |
| FDA-2026-N-9638-0001 | FDA | FDA-2026-N-9638 | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products | Notice | 60 Day Proposed Information Collection | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-09-29 09:00:25 | 2026-18333 | 1 | 0 | 09000064b9506ea0 |
| FDA-2026-N-8361-0001 | FDA | FDA-2026-N-8361 | Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications | Notice | 60 Day Proposed Information Collection | 2026-09-09 | 2026 | 9 | 2026-09-09 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-10-03 09:00:40 | 2026-18299 | 1 | 0 | 09000064b9506ef8 |
| FDA-2026-N-10738-0001 | FDA | FDA-2026-N-10738 | Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information | Notice | Requests for Information (RFI) | 2026-09-24 | 2026 | 9 | 2026-09-24 | 2026-11-09 | 2026-11-10 04:59:59 | 0 | 2026-10-08 09:00:48 | 2026-19563 | 1 | 0 | 09000064b95b6b07 |
| FDA-2026-N-7605-0001 | FDA | FDA-2026-N-7605 | Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information | Notice | Requests for Information (RFI) | 2026-08-05 | 2026 | 8 | 2026-08-05 | 2026-11-03 | 2026-11-04 04:59:59 | 0 | 2026-10-03 09:00:26 | 2026-15887 | 1 | 0 | 09000064b93ff4d4 |
| FDA-2026-N-9550-0001 | FDA | FDA-2026-N-9550 | Advancing Development of Botanical Drug Products; Request for Information | Notice | Requests for Information (RFI) | 2026-09-04 | 2026 | 9 | 2026-09-04 | 2026-11-03 | 2026-11-04 04:59:59 | 0 | 2026-10-08 09:00:45 | 2026-18133 | 1 | 0 | 09000064b94cc083 |
| FDA-2026-N-7914-0001 | FDA | FDA-2026-N-7914 | Public Meeting on Listeria monocytogenes Prevention | Other | Additional Information | 2026-08-03 | 2026 | 8 | 2026-08-03 | 2026-11-02 | 2026-11-03 04:59:59 | 0 | 2026-08-19 09:01:12 | 1 | 0 | 09000064b93e5b66 | |
| FDA-2026-N-6876-0005 | FDA | FDA-2026-N-6876 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program | Notice | 30 Day Proposed Information Collection | 2026-10-01 | 2026 | 10 | 2026-10-01 | 2026-11-02 | 2026-11-03 04:59:59 | 0 | 2026-10-01 17:10:26 | 2026-20085 | 1 | 0 | 09000064b95fa835 |
| FDA-2026-N-8690-0001 | FDA | FDA-2026-N-8690 | Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees | Notice | 60 Day Proposed Information Collection | 2026-08-31 | 2026 | 8 | 2026-08-31 | 2026-10-30 | 2026-10-31 03:59:59 | 0 | 2026-08-31 17:28:32 | 2026-17676 | 1 | 0 | 09000064b94afcfe |
| FDA-2026-N-9349-0001 | FDA | FDA-2026-N-9349 | Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections | Notice | 60 Day Proposed Information Collection | 2026-08-31 | 2026 | 8 | 2026-08-31 | 2026-10-30 | 2026-10-31 03:59:59 | 0 | 2026-08-31 17:33:15 | 2026-17675 | 1 | 0 | 09000064b94afbd8 |
| FDA-2026-N-2743-0003 | FDA | FDA-2026-N-2743 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 | Notice | 30 Day Proposed Information Collection | 2026-09-29 | 2026 | 9 | 2026-09-29 | 2026-10-29 | 2026-10-30 03:59:59 | 0 | 2026-09-29 17:13:03 | 2026-19850 | 1 | 0 | 09000064b95e920c |
| FDA-2026-N-10606-0001 | FDA | FDA-2026-N-10606 | Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application (NDA) 219694 for Atropine Sulfate Ophthalmic Solution, 0.01% | Notice | Request for Comments | 2026-09-25 | 2026 | 9 | 2026-09-25 | 2026-10-29 | 2026-10-30 03:59:59 | 0 | 2026-10-08 09:00:48 | 2026-19700 | 1 | 0 | 09000064b95c540b |
| FDA-2026-N-8691-0001 | FDA | FDA-2026-N-8691 | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers | Notice | 60 Day Proposed Information Collection | 2026-08-28 | 2026 | 8 | 2026-08-28 | 2026-10-27 | 2026-10-28 03:59:59 | 0 | 2026-08-28 17:30:23 | 2026-17599 | 1 | 0 | 09000064b94a6404 |
| FDA-2026-N-8087-0001 | FDA | FDA-2026-N-8087 | Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration | Notice | 60 Day Proposed Information Collection | 2026-08-28 | 2026 | 8 | 2026-08-28 | 2026-10-27 | 2026-10-28 03:59:59 | 0 | 2026-08-28 17:52:27 | 2026-17598 | 1 | 0 | 09000064b949f63c |
| FDA-2026-N-8898-0001 | FDA | FDA-2026-N-8898 | Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery | Notice | 60 Day Proposed Information Collection | 2026-08-28 | 2026 | 8 | 2026-08-28 | 2026-10-27 | 2026-10-28 03:59:59 | 0 | 2026-09-06 09:00:29 | 2026-17605 | 1 | 0 | 09000064b94a6385 |
| FDA-2026-N-8482-0001 | FDA | FDA-2026-N-8482 | Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health | Notice | Request for Comments | 2026-08-26 | 2026 | 8 | 2026-08-26 | 2026-10-26 | 2026-10-27 03:59:59 | 0 | 2026-08-27 09:00:24 | 2026-17377 | 1 | 0 | 09000064b94982b2 |
| FDA-2026-N-5057-0001 | FDA | FDA-2026-N-5057 | Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments | Notice | Request for Comments | 2026-05-29 | 2026 | 5 | 2026-05-29 | 2026-10-26 | 2026-10-27 03:59:59 | 0 | 2026-09-30 09:00:14 | 2026-10752 | 1 | 0 | 09000064b92fcf66 |
| FDA-2021-F-1157-0003 | FDA | FDA-2021-F-1157 | Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast | Rule | Final Rule | 2026-09-25 | 2026 | 9 | 2026-09-25 | 2026-10-26 | 2026-10-27 03:59:59 | 0 | 2026-10-05 09:00:31 | 2026-19656 | 1 | 0 | 09000064b95c657c |
| FDA-2007-D-0369-2652 | FDA | FDA-2007-D-0369 | PSG_020816 - Draft Guidance on Brinzolamide | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:08:40 | 1 | 0 | 09000064b9470607 | |
| FDA-2007-D-0369-2653 | FDA | FDA-2007-D-0369 | PSG_020732 - Draft Guidance on Buprenorphine | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:08:45 | 1 | 0 | 09000064b94706ae | |
| FDA-2007-D-0369-2654 | FDA | FDA-2007-D-0369 | PSG_204370 - Draft Guidance on Cariprazine Hydrochloride | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:08:55 | 1 | 0 | 09000064b94706b0 | |
| FDA-2007-D-0369-2655 | FDA | FDA-2007-D-0369 | PSG_050600 - Draft Guidance on Clindamycin Phosphate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:04 | 1 | 0 | 09000064b94706b2 | |
| FDA-2007-D-0369-2656 | FDA | FDA-2007-D-0369 | PSG_215425 - Draft Guidance on Epinephrine | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:08 | 1 | 0 | 09000064b94706b4 | |
| FDA-2007-D-0369-2657 | FDA | FDA-2007-D-0369 | PSG_218475 - Draft Guidance on Epinephrine Bitartrate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:13 | 1 | 0 | 09000064b94706b6 | |
| FDA-2007-D-0369-2658 | FDA | FDA-2007-D-0369 | PSG_203565 - Draft Guidance on Ferric Carboxymaltose | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:18 | 1 | 0 | 09000064b94706b8 | |
| FDA-2007-D-0369-2659 | FDA | FDA-2007-D-0369 | PSG_022180 - Draft Guidance on Ferumoxytol | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:23 | 1 | 0 | 09000064b94706ba | |
| FDA-2007-D-0369-2660 | FDA | FDA-2007-D-0369 | PSG_020243 - Draft Guidance on Fluvoxamine Maleate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:28 | 1 | 0 | 09000064b94706bc | |
| FDA-2007-D-0369-2661 | FDA | FDA-2007-D-0369 | PSG_020496 - Draft Guidance on Glimepiride | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:33 | 1 | 0 | 09000064b94706be | |
| FDA-2007-D-0369-2662 | FDA | FDA-2007-D-0369 | PSG_213876 - Draft Guidance on Hydrocortisone | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:38 | 1 | 0 | 09000064b94706c0 | |
| FDA-2007-D-0369-2663 | FDA | FDA-2007-D-0369 | PSG_206185 - Draft Guidance on Latanoprost | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:09:42 | 1 | 0 | 09000064b94706c2 | |
| FDA-2007-D-0369-2664 | FDA | FDA-2007-D-0369 | PSG_209939 - Draft Guidance on Letermovir | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:09 | 1 | 0 | 09000064b94706c4 | |
| FDA-2007-D-0369-2665 | FDA | FDA-2007-D-0369 | PSG_021343 - Draft Guidance on Leuprolide Acetate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:14 | 1 | 0 | 09000064b94706c6 | |
| FDA-2007-D-0369-2666 | FDA | FDA-2007-D-0369 | PSG_021379 - Draft Guidance on Leuprolide Acetate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:19 | 1 | 0 | 09000064b94706c8 | |
| FDA-2007-D-0369-2667 | FDA | FDA-2007-D-0369 | PSG_021731 - Draft Guidance on Leuprolide Acetate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:24 | 1 | 0 | 09000064b94706ca | |
| FDA-2007-D-0369-2668 | FDA | FDA-2007-D-0369 | PSG_021924 - Draft Guidance on Levothyroxine Sodium | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:29 | 1 | 0 | 09000064b94706cc | |
| FDA-2007-D-0369-2669 | FDA | FDA-2007-D-0369 | PSG_215029 - Draft Guidance on Lidocaine | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:35 | 1 | 0 | 09000064b94706ce | |
| FDA-2007-D-0369-2670 | FDA | FDA-2007-D-0369 | PSG_021977 - Draft Guidance on Lisdexamfetamine Dimesylate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:41 | 1 | 0 | 09000064b94706d0 | |
| FDA-2007-D-0369-2671 | FDA | FDA-2007-D-0369 | PSG_219847 - Draft Guidance on Lisdexamfetamine Dimesylate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:46 | 1 | 0 | 09000064b94706d2 | |
| FDA-2007-D-0369-2672 | FDA | FDA-2007-D-0369 | PSG_219485 - Draft Guidance on Maralixibat Chloride | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:10:51 | 1 | 0 | 09000064b94706d4 | |
| FDA-2007-D-0369-2673 | FDA | FDA-2007-D-0369 | PSG_214662 - Draft Guidance on Maralixibat Chloride | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:06 | 1 | 0 | 09000064b94706d6 | |
| FDA-2007-D-0369-2674 | FDA | FDA-2007-D-0369 | PSG_217593 - Draft Guidance on Meloxicam | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:11 | 1 | 0 | 09000064b94706d8 | |
| FDA-2007-D-0369-2675 | FDA | FDA-2007-D-0369 | PSG_218395 - Draft Guidance on Meloxicam | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:15 | 1 | 0 | 09000064b94706da | |
| FDA-2007-D-0369-2676 | FDA | FDA-2007-D-0369 | PSG_215211 - Draft Guidance on Miglustat | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:20 | 1 | 0 | 09000064b94706dc | |
| FDA-2007-D-0369-2677 | FDA | FDA-2007-D-0369 | PSG_020415 - Draft Guidance on Mirtazapine | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:25 | 1 | 0 | 09000064b94706de | |
| FDA-2007-D-0369-2678 | FDA | FDA-2007-D-0369 | PSG_215793 - Draft Guidance on Mitomycin | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:30 | 1 | 0 | 09000064b94706e0 | |
| FDA-2007-D-0369-2679 | FDA | FDA-2007-D-0369 | PSG_203340 - Draft Guidance on Nimodipine | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:34 | 1 | 0 | 09000064b94706e2 | |
| FDA-2007-D-0369-2680 | FDA | FDA-2007-D-0369 | PSG_021008 - Draft Guidance on Octreotide Acetate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:40 | 1 | 0 | 09000064b9470826 | |
| FDA-2007-D-0369-2681 | FDA | FDA-2007-D-0369 | PSG_208558 - Draft Guidance on Olaparib | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:45 | 1 | 0 | 09000064b9470828 | |
| FDA-2007-D-0369-2683 | FDA | FDA-2007-D-0369 | PSG_020781 - Draft Guidance on Ondansetron | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:11:55 | 1 | 0 | 09000064b947082c | |
| FDA-2007-D-0369-2684 | FDA | FDA-2007-D-0369 | PSG_211150 - Draft Guidance on Pitolisant Hydrochloride | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:12:15 | 1 | 0 | 09000064b947082e | |
| FDA-2007-D-0369-2685 | FDA | FDA-2007-D-0369 | PSG_219685 - Draft Guidance on Rilzabrutinib | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:12:21 | 1 | 0 | 09000064b9470830 | |
| FDA-2007-D-0369-2686 | FDA | FDA-2007-D-0369 | PSG_219301 - Draft Guidance on Sebetralstat | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:12:25 | 1 | 0 | 09000064b9470832 | |
| FDA-2007-D-0369-2687 | FDA | FDA-2007-D-0369 | PSG_020573 - Draft Guidance on Sodium Phenylbutyrate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:12:30 | 1 | 0 | 09000064b9470834 | |
| FDA-2007-D-0369-2688 | FDA | FDA-2007-D-0369 | PSG_214860 - Draft Guidance on Sodium Phenylbutyrate | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:12:41 | 1 | 0 | 09000064b9470836 | |
| FDA-2007-D-0369-2689 | FDA | FDA-2007-D-0369 | PSG_219839 - Draft Guidance on Sunvozertinib | Other | Guidance | 2026-08-24 | 2026 | 8 | 2026-08-24 | 2026-10-23 | 2026-10-24 03:59:59 | 0 | 2026-08-24 20:12:46 | 1 | 0 | 09000064b9470838 |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT,
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT, -- EASTERN calendar date of the close (queue #498 writer
-- fix, 2026-09-05; was the UTC-rolled day AFTER the ET
-- deadline before that). Display-grade only.
comment_end_datetime TEXT, -- full UTC close ("YYYY-MM-DD HH:MM:SS", queue #498):
-- the API expresses the 11:59:59 PM ET deadline as a UTC
-- datetime. AUTHORITATIVE: the predicate, days_left and
-- any timezone-aware render derive from THIS column.
perpetual_docket INTEGER, -- 1 = sentinel end date (queue #464); NULL = no end date
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date);
CREATE INDEX idx_docs_withdrawn ON documents(withdrawn);
CREATE INDEX idx_docs_perpetual ON documents(perpetual_docket);
document_type 4