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withdrawn,object_id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-2013-D-0576-0019,FDA,FDA-2013-D-0576,"Considerations for the Design of Early-Phase Clinical Trials of Cellular and
Gene Therapy Products; Guidance for Industry",Other,Guidance,2015-06-27T04:00:00Z,2015,6,2015-06-27T04:00:00Z,,2024-11-11T20:58:54Z,,1,0,0900006481b2cd22
FDA-2013-D-0576-0026,FDA,FDA-2013-D-0576,Reference 6 Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:25:50Z,,0,0,0900006481b2cdca
FDA-2013-D-0576-0030,FDA,FDA-2013-D-0576,Reference 10 Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration_Regulated Products 78FedReg12937 2-26-13 re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:26:55Z,,0,0,0900006481b2c9dd
FDA-2013-D-0576-0034,FDA,FDA-2013-D-0576,Reference 14 Target Product Profile_A Strategic Development Process Tool re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:27:16Z,,0,0,0900006481b2c9e1
FDA-2013-D-0576-0027,FDA,FDA-2013-D-0576,"Reference 7 Stem Cell-Derived Cardiomyocytes Demonstrate Arrhythmic Potential, Circulation re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry",Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:26:12Z,,0,0,0900006481b2cdcb
FDA-2013-D-0576-0022,FDA,FDA-2013-D-0576,"Reference 2 Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry",Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:25:22Z,,0,0,0900006481b2cdce
FDA-2013-D-0576-0023,FDA,FDA-2013-D-0576,Reference 3 Preclinical Assessment of Investigational Cellular and Gene Therapy Products re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:25:28Z,,0,0,0900006481b2c9db
FDA-2013-D-0576-0028,FDA,FDA-2013-D-0576,Reference 8 Molecular Imaging of Stem Cells Tracking Survival BiodistributionTumorigenicity and Immunogenicity re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:26:18Z,,0,0,0900006481b2cdcc
FDA-2013-D-0576-0021,FDA,FDA-2013-D-0576,"Reference 1 Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry",Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:25:16Z,,0,0,0900006481b2cdcd
FDA-2013-D-0576-0020,FDA,FDA-2013-D-0576,Reference List re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:19:43Z,,0,0,0900006481b2cdc6
FDA-2013-D-0576-0031,FDA,FDA-2013-D-0576,Reference 11 Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:27:00Z,,0,0,0900006481b2c9de
FDA-2013-D-0576-0033,FDA,FDA-2013-D-0576,"Reference 13 Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well_Characterized, Therapeutic, Biotechnolgy_derived Products re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry",Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:27:11Z,,0,0,0900006481b2c9e0
FDA-2013-D-0576-0029,FDA,FDA-2013-D-0576,Reference 9 E11 Clinical Investigation of Medicinal Products in the Pediatric Population re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:26:50Z,,0,0,0900006481b2c9dc
FDA-2013-D-0576-0025,FDA,FDA-2013-D-0576,Reference 5  LMO2-Associated Clonal T Cell Proliferation in Two Patients after Gene Therapy for SCID-X1 re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:25:44Z,,0,0,0900006481b2cdc9
FDA-2013-D-0576-0024,FDA,FDA-2013-D-0576,"Reference  4 Fatal systemic inflammatory response syndrome re Considerations for the Design of Early-Phase Clinical Trials of Cellular and
Gene Therapy Products; Guidance for Industry",Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:25:38Z,,0,0,0900006481b2cdc8
FDA-2013-D-0576-0018,FDA,FDA-2013-D-0576,"Considerations for the Design of Early-Phase Clinical Trials of Cellular and
Gene Therapy Products; Guidance for Industry; Availability",Notice,Notice of Availability,2015-06-11T04:00:00Z,2015,6,2015-06-11T04:00:00Z,,2015-06-11T13:36:30Z,2015-14261,0,0,0900006481b2c674
FDA-2013-D-0576-0032,FDA,FDA-2013-D-0576,Reference 12 Formal Meetings Between the FDA and Sponsors or Applicants re Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry,Supporting & Related Material,Background Material,2015-06-11T04:00:00Z,2015,6,,,2015-06-11T14:27:06Z,,0,0,0900006481b2c9df