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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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20 rows where docket_id = "FDA-2013-D-0576" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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
FDA-2013-D-0576-0003 FDA None FDA-2013-D-0576 Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period Notice Notice of Availability 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-05-10T03:59:59Z 2014-05-13T14:34:04Z 2013-27769 0 0 090000648148ba3d
FDA-2013-D-0576-0001 FDA None FDA-2013-D-0576 Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability Notice Notice of Availability 2013-07-02T04:00:00Z 2013 7 2013-07-02T04:00:00Z 2013-11-23T04:59:59Z 2014-01-31T02:02:34Z 2013-15797 0 0 09000064813517c4
FDA-2013-D-0576-0002 FDA None FDA-2013-D-0576 Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products Other Guidance 2013-07-02T04:00:00Z 2013 7 2013-07-02T04:00:00Z   2024-11-12T05:16:03Z   1 0 0900006481350f90

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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;