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withdrawn,object_id FDA-2026-D-1255-0001,FDA,FDA-2026-D-1255,Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2026-04-15T04:00:00Z,2026,4,2026-04-15T04:00:00Z,,2026-04-15T17:11:56Z,2026-07285,0,0,09000064b92810b1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,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3 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry*, Sept. 2023",Supporting & Related Material,Background Material,2026-04-15T04:00:00Z,2026,4,,,2026-04-15T17:30:41Z,,0,0,09000064b9282a37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,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,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Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry,Other,Guidance,2026-04-15T04:00:00Z,2026,4,2026-04-15T04:00:00Z,2026-07-15T03:59:59Z,2026-05-15T09:00:20Z,,1,0,09000064b9282a2a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,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