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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

16 rows where docket_id = "FDA-2025-N-1243" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 15
  • Proposed Rule 1

posted_year 1

  • 2025 16

agency_id 1

  • FDA 16
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2025-N-1243-0003 FDA None FDA-2025-N-1243 Reference 1 - In Vitro Companion Diagnostic Devices – Guidance for Industry and Food and Drug Administration Staff, issued August 6, 2014 Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:34:01Z   0 0 09000064b8dee62b
FDA-2025-N-1243-0004 FDA None FDA-2025-N-1243 Reference 2 - P980024/S001 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:35:08Z   0 0 09000064b8dee62c
FDA-2025-N-1243-0008 FDA None FDA-2025-N-1243 Reference 6 - P100024 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:35:48Z   0 0 09000064b8df61ae
FDA-2025-N-1243-0011 FDA None FDA-2025-N-1243 Reference 9 - P150041 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:36:19Z   0 0 09000064b8df61b8
FDA-2025-N-1243-0015 FDA None FDA-2025-N-1243 Reference 13 - Manning JE, Hershey ND, Broker TR, Pellegrini M, Mitchell HK, Davidson N. A new method of in situ hybridization Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:37:35Z   0 0 09000064b8df61bf
FDA-2025-N-1243-0001 FDA None FDA-2025-N-1243 Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product Proposed Rule Request for Comment 2025-06-11T04:00:00Z 2025 6 2025-06-11T04:00:00Z 2025-08-12T03:59:59Z 2025-08-12T09:00:21Z 2025-10549 0 0 09000064b8ded24e
FDA-2025-N-1243-0005 FDA None FDA-2025-N-1243 Reference 3 - “Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997,” issued on August 9, 2000 Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:35:18Z   0 0 09000064b8df619f
FDA-2025-N-1243-0006 FDA None FDA-2025-N-1243 Reference 4 - P040005 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:35:28Z   0 0 09000064b8df61a4
FDA-2025-N-1243-0009 FDA None FDA-2025-N-1243 Reference 7 - P100027 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:35:57Z   0 0 09000064b8df61b4
FDA-2025-N-1243-0012 FDA None FDA-2025-N-1243 Reference 10 - Curtin, SC, Tejada-Vera, B, Bastian, Deaths: Leading Causes for 2021. National Center for Health Statistics. Vital Health Stat 73(4). 2024 Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:36:44Z   0 0 09000064b8df61ba
FDA-2025-N-1243-0016 FDA None FDA-2025-N-1243 Reference 14 - Bauman JG, Wiegant J, Borst P, van Duijn P. A new method for fluorescence microscopical localization of specific DNA sequences by in situ hybridization of fluorochromelabelled RNA Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:37:59Z   0 0 09000064b8df61c1
FDA-2025-N-1243-0010 FDA None FDA-2025-N-1243 Reference 8 - P110012 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:36:10Z   0 0 09000064b8df61b6
FDA-2025-N-1243-0013 FDA None FDA-2025-N-1243 Reference 11- Chu YH, Hardin H, Zhang R, Guo Z, Lloyd RV. In situ hybridization: Introduction to techniques, applications and pitfalls in the performance and interpretation of assays Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:37:00Z   0 0 09000064b8df61bd
FDA-2025-N-1243-0007 FDA None FDA-2025-N-1243 Reference 5 - P050040 Summary of Safety and Effectiveness Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:35:40Z   0 0 09000064b8df61a7
FDA-2025-N-1243-0002 FDA None FDA-2025-N-1243 List of References Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:33:51Z   0 0 09000064b8dee629
FDA-2025-N-1243-0014 FDA None FDA-2025-N-1243 Reference 12 - du Sart, D., Andy Choo, K.H. (1998). The Technique of In Situ Hybridization. In: Rapley, R., Walker, J.M. (eds) Molecular Biomethods Handbook. Springer Protocols Handbooks Supporting & Related Material Background Material 2025-06-11T04:00:00Z 2025 6     2025-06-11T23:37:27Z   0 0 09000064b8df61be

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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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