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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

10 rows where agency_id = "FDA", docket_id = "FDA-2005-N-0464" and posted_year = 2009 sorted by posted_date descending

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

document_type 2

  • Other 8
  • Notice 2

posted_year 1

  • 2009 · 10 ✖

agency_id 1

  • FDA · 10 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0464-0232 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability Notice NAD-Notice of Availability of Data 2009-06-01T04:00:00Z 2009 6 2009-06-01T04:00:00Z 2009-06-02T03:59:59Z 2010-08-13T15:19:06Z E9-12743 0 0 09000064809c1db8
FDA-2005-N-0464-0231 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Guideline re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability Other Guidance 2009-06-01T04:00:00Z 2009 6 2009-06-01T04:00:00Z   2016-12-08T18:55:55Z   0 0 09000064809c15da
FDA-2005-N-0464-0230 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Notice of Availability of Data re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability Notice Notice of Availability 2009-06-01T04:00:00Z 2009 6 2009-06-01T04:00:00Z 2009-06-02T03:59:59Z 2020-10-10T01:01:27Z E9-12743 0 0 09000064809c0c71
FDA-2005-N-0464-0233 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing Other Guidance 2009-05-28T04:00:00Z 2009 5 2009-05-28T04:00:00Z   2020-10-10T01:01:01Z   0 0 09000064809c1ad2
FDA-2005-N-0464-0229 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Compressed Gas Association - Supplement Comment [re FDA-2005-N-0464-0080.1] Other SUP-Supplement 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2014-12-16T22:17:42Z   0 0 090000648095560b
FDA-2005-N-0464-0222 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Hospira Inc. - "The Proposed Changes to NDC System Legacy NDC Numbers and Compliance " (Thomas F. Willer) - Testimony Other TS-Testimony 2009-04-15T04:00:00Z 2009 4 2009-04-15T04:00:00Z   2017-01-18T17:36:54Z   0 0 0900006480450c46
FDA-2005-N-0464-0223 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Perrigo - "Experience with NDC Numbers" - Testimony Other TS-Testimony 2009-04-15T04:00:00Z 2009 4 2009-04-15T04:00:00Z   2017-01-18T17:38:31Z   0 0 0900006480450c48
FDA-2005-N-0464-0224 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Consumer Healthcare Products Association (CHPA) - ""FDA Public Meeting – Proposed Changes to the National Drug Code (NDC) Number System" (Paul J. Larsen) - Testimony Other TS-Testimony 2009-04-15T04:00:00Z 2009 4 2009-04-15T04:00:00Z   2017-01-18T17:40:20Z   0 0 0900006480450c4a
FDA-2005-N-0464-0226 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 Guidance for Industry Providing Regulatory Submissions in Electronic Format -Drug Establishment Registration and Drug Listing Other GDL-Guidance (Supporting and Related Materials) 2009-04-15T04:00:00Z 2009 4 2009-04-15T04:00:00Z   2019-10-17T19:56:23Z   0 0 0900006480667d76
FDA-2005-N-0464-0225 FDA Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs FDA-2005-N-0464 AABB - "National Drug Codes for HCT/Ps" (M. Allene Carr-Greer) - Testimony Other TS-Testimony 2009-04-15T04:00:00Z 2009 4 2009-04-15T04:00:00Z   2017-01-18T17:41:41Z   0 0 0900006480450c4f

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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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