documents
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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Suggested facets: subtype, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;