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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

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)

document_type 3

  • Supporting & Related Material 3
  • Notice 1
  • Other 1

posted_year 1

  • 2026 5

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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FDA Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability Notice Notice of Availability 2026-04-15T04:00:00Z 2026 4 2026-04-15T04:00:00Z   2026-04-15T17:11:56Z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FDA Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 Reference 3 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry*, Sept. 2023 Supporting & Related Material Background Material 2026-04-15T04:00:00Z 2026 4     2026-04-15T17:30:41Z   0 0 09000064b9282a37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FDA Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 Reference 2 - OTP Pre-IND Meetings, last updated Aug. 2024 Supporting & Related Material Background Material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FDA Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability FDA-2026-D-1255 Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry Other Guidance 2026-04-15T04:00:00Z 2026 4 2026-04-15T04:00:00Z 2026-07-15T03:59:59Z 2026-05-15T09:00:20Z   1 0 09000064b9282a2a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;
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