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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

21 rows where docket_id = "FDA-2021-N-0862" and posted_year = 2024 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 20
  • Rule 1

posted_year 1

  • 2024 · 21 ✖

agency_id 1

  • FDA 21
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2021-N-0862-0219 FDA None FDA-2021-N-0862 Reference 10 - FDA Combination Products web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c405
FDA-2021-N-0862-0226 FDA None FDA-2021-N-0862 Reference 18 - 73 FR 63491_Docket FDA-2008-N-0549_10-24-2008 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:49Z   0 0 090000648688c497
FDA-2021-N-0862-0227 FDA None FDA-2021-N-0862 Reference 19 - 83 FR 40973_Docket FDA-2017-N-6730_08-17-2018 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:54Z   0 0 090000648688c4a8
FDA-2021-N-0862-0215 FDA None FDA-2021-N-0862 Reference 7a - NPSA_Guide to Graphic Design of Medication Packaging 2nd Ed_2007 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:59:19Z   0 0 090000648688c3cb
FDA-2021-N-0862-0218 FDA None FDA-2021-N-0862 Reference 9 - FDA eCTD Resources web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c403
FDA-2021-N-0862-0223 FDA None FDA-2021-N-0862 Reference 15 - 83 FR 13394_Docket FDA-2008-N-0549_04-02-2018 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:19Z   0 0 090000648688c490
FDA-2021-N-0862-0225 FDA None FDA-2021-N-0862 Reference 17 - 87 FR 68702_Docket FDA-2022-N-2673_11-16-2022 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:41Z   0 0 090000648688c493
FDA-2021-N-0862-0220 FDA None FDA-2021-N-0862 Reference 11 - MOU Between the FTC and FDA Concerning the Exchange of Information (FDA-225-71-8003)_April 1971 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:59:53Z   0 0 090000648688c406
FDA-2021-N-0862-0217 FDA None FDA-2021-N-0862 Reference 8 - USP_Recommendations to the Safe Medication Use Expert Committee by the Health Literacy and Prescription Container Labeling Advisory Panel_2010 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:59:32Z   0 0 090000648688c402
FDA-2021-N-0862-0208 FDA None FDA-2021-N-0862 Reference List - Nonprescription Drug Product With an Additional Condition for Nonprescription Use - Final Rule Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:28Z   0 0 090000648688c868
FDA-2021-N-0862-0207 FDA None FDA-2021-N-0862 Nonprescription Drug Product With an Additional Condition for Nonprescription Use Rule Final Rule 2024-12-26T05:00:00Z 2024 12 2024-12-26T05:00:00Z   2024-12-26T15:41:32Z 2024-30261 0 0 090000648688bfbc
FDA-2021-N-0862-0216 FDA None FDA-2021-N-0862 Reference 7b - NPSA_Guide to Labelling and Packaging of Injectable Medicines_1st Ed_2007 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:59:23Z   0 0 090000648688c3cc
FDA-2021-N-0862-0209 FDA None FDA-2021-N-0862 Reference 1 - FDA Guidance for Industry_Label -Comprehension-Studies-for-Nonprescription-Drug-Products_Aug2010 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:33Z   0 0 090000648688c8ae
FDA-2021-N-0862-0212 FDA None FDA-2021-N-0862 Reference 4 - FDA Guidance for Industry and FDA Staff_Policy for Device Software Functions and Mobile Medical Applications Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:49Z   0 0 090000648688c8b3
FDA-2021-N-0862-0213 FDA None FDA-2021-N-0862 Reference 5 - FDA Medwatch The FDA Safety Information and Adverse Event Reporting Program Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c3c7
FDA-2021-N-0862-0221 FDA None FDA-2021-N-0862 Reference 12 - FDA Prescription to Over-the-Counter (OTC) Switch List web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:37Z   0 0 090000648688c407
FDA-2021-N-0862-0211 FDA None FDA-2021-N-0862 Reference 3 - FDA Guidance for Industry_Application of Human Factors Engineering Principles for Combination Products QA_Sept2023 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:45Z   0 0 090000648688c8b1
FDA-2021-N-0862-0222 FDA None FDA-2021-N-0862 Reference 14 - 87 FR 38313_Docket FDA-2021-N-0862_06-28-2022 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:08Z   0 0 090000648688c986
FDA-2021-N-0862-0224 FDA None FDA-2021-N-0862 Reference 16 - 70 FR 52050_Docket 2005N-0345_09-01-2005 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T20:00:32Z   0 0 090000648688c491
FDA-2021-N-0862-0210 FDA None FDA-2021-N-0862 Reference 2 - FDA Guidance for Industry_Self-Selection-Studies-for-Nonprescription-Drug-Products_April2013 Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2024-12-26T19:58:41Z   0 0 090000648688c8b0
FDA-2021-N-0862-0214 FDA None FDA-2021-N-0862 Reference 6 - FDA Consumer Complaint Coordinators web page Supporting & Related Material Background Material 2024-12-26T05:00:00Z 2024 12     2025-02-23T18:35:38Z   0 0 090000648688c3c8

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    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_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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