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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

14 rows where docket_id = "FDA-2005-D-0208" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 3

  • Supporting & Related Material 10
  • Notice 2
  • Other 2

posted_year 2

  • 2008 12
  • 2005 2

agency_id 1

  • FDA 14
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-D-0208-0006 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 2 - FDA Blood Products Advisory Committee Meeting, March 2000 [FDA-2005-D-0208-0004] - Transcript Supporting & Related Material REF-Reference Material (external attachments) 2008-07-18T04:00:00Z 2008 7     2008-07-18T20:39:43Z   0 0 090000648067609f
FDA-2005-D-0208-0007 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 5 - Draft Guidance for Industry General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products, November 1998 [FDA-2005-D-0208-0004] - Draft Guidance Document Supporting & Related Material REF-Reference (internal unless indicated) 2008-07-18T04:00:00Z 2008 7     2008-07-18T20:40:36Z   0 0 0900006480676155
FDA-2005-D-0208-0014 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 4 - Background Material for NAD1[FDA-2005-D-0208-0002] Supporting & Related Material BKG-Background Material 2008-07-18T04:00:00Z 2008 7     2008-07-20T05:27:20Z   0 0 0900006480441243
FDA-2005-D-0208-0009 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 17 - Guidance for Industry "Community Acquired Pneumonia - Developing Antimicrobial Drugs for Treatment [FDA-2005-D-0208-0004] - Draft Guidance Document Supporting & Related Material REF-Reference (internal unless indicated) 2008-07-18T04:00:00Z 2008 7     2008-07-18T20:50:33Z   0 0 0900006480676a57
FDA-2005-D-0208-0011 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 1 - Background Material for NAD1[FDA-2005-D-0208-0002] - Draft Guidance Document Supporting & Related Material BKG-Background Material 2008-07-18T04:00:00Z 2008 7     2008-07-18T04:58:03Z   0 0 0900006480441246
FDA-2005-D-0208-0008 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 16 - Guidance for Industry "Acute Bacterial Meningitis - Developing Antimicrobial Drugs for Treatment [FDA-2005-D-0208-0004] - Draft Guidance Document Supporting & Related Material REF-Reference (internal unless indicated) 2008-07-18T04:00:00Z 2008 7     2008-07-18T20:46:02Z   0 0 0900006480676990
FDA-2005-D-0208-0010 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Background Material for NAD1 [FDA-2005-D-0208-0002] - Reference List Supporting & Related Material BKG-Background Material 2008-07-18T04:00:00Z 2008 7     2008-07-18T04:58:02Z   0 0 0900006480441247
FDA-2005-D-0208-0005 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 1 - FDA Blood Products Advisory Committee Meeting, March 1999, [FDA-2005-D-0208-0004] - Transcript Supporting & Related Material REF-Reference (internal unless indicated) 2008-07-18T04:00:00Z 2008 7     2008-07-18T20:38:29Z   0 0 0900006480676030
FDA-2005-D-0208-0012 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 2 - Background Material for NAD1[FDA-2005-D-0208-0002] Supporting & Related Material BKG-Background Material 2008-07-18T04:00:00Z 2008 7     2008-07-18T04:58:04Z   0 0 0900006480441248
FDA-2005-D-0208-0013 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Reference 3 - Background Material for NAD1 Blood Products Advisory Committee Meeting, March 2000[FDA-2005-D-0208-0002] - Transcript Supporting & Related Material BKG-Background Material 2008-07-18T04:00:00Z 2008 7     2008-07-18T04:58:05Z   0 0 0900006480441245
FDA-2005-D-0208-0004 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency Other Guidance 2008-07-17T04:00:00Z 2008 7 2008-07-17T04:00:00Z   2024-11-12T04:21:43Z   1 0 0900006480680037
FDA-2005-D-0208-0003 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Availability Notice NAD-Notice of Availability of Data 2008-07-17T04:00:00Z 2008 7 2008-07-17T04:00:00Z   2008-07-17T12:54:19Z E8-16395 0 0 090000648067fb8d
FDA-2005-D-0208-0002 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Draft Guidance Document Other GDL-Guidance (Supporting and Related Materials) 2005-12-02T05:00:00Z 2005 12     2008-07-18T05:20:46Z   0 0 090000648044123a
FDA-2005-D-0208-0001 FDA Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Availability Notice NAD-Notice of Availability of Data 2005-12-02T05:00:00Z 2005 12 2005-11-30T05:00:00Z 2006-03-02T04:59:59Z 2008-07-18T05:09:10Z   0 0 0900006480441234

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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);
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