documents
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
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency FDA-2005-D-0208 | Reference 5 - Draft Guidance for Industry General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products, November 1998 [FDA-2005-D-0208-0004] - Draft Guidance Document | Supporting & Related Material | REF-Reference (internal unless indicated) | 2008-07-18T04:00:00Z | 2008 | 7 | 2008-07-18T20:40:36Z | 0 | 0 |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);