documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
5 rows where docket_id = "FDA-2026-D-1255" sorted by posted_date descending
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Suggested facets: subtype, open_for_comment, 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2026-D-1255-0001 | FDA | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability | Notice | Notice of Availability | 2026-04-15T04:00:00Z | 2026 | 4 | 2026-04-15T04:00:00Z | 2026-04-15T17:11:56Z | 2026-07285 | 0 | 0 | 09000064b92810b1 | |
| FDA-2026-D-1255-0005 | FDA | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 | Reference 3 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry*, Sept. 2023 | Supporting & Related Material | Background Material | 2026-04-15T04:00:00Z | 2026 | 4 | 2026-04-15T17:30:41Z | 0 | 0 | 09000064b9282a37 | |||
| FDA-2026-D-1255-0004 | FDA | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 | Reference 2 - OTP Pre-IND Meetings, last updated Aug. 2024 | Supporting & Related Material | Background Material | 2026-04-15T04:00:00Z | 2026 | 4 | 2026-04-15T17:27:58Z | 0 | 0 | 09000064b9282a33 | |||
| FDA-2026-D-1255-0002 | FDA | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry | Other | Guidance | 2026-04-15T04:00:00Z | 2026 | 4 | 2026-04-15T04:00:00Z | 2026-07-15T03:59:59Z | 2026-05-15T09:00:20Z | 1 | 0 | 09000064b9282a2a | |
| FDA-2026-D-1255-0003 | FDA | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 | Reference 1 - Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry, January 2024 | Supporting & Related Material | Background Material | 2026-04-15T04:00:00Z | 2026 | 4 | 2026-04-15T17:24:48Z | 0 | 0 | 09000064b9282a32 |
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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;