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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

22 rows where docket_id = "FDA-2005-P-0253" sorted by posted_date descending

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

posted_year 3

  • 2007 18
  • 2005 3
  • 2006 1

document_type 1

  • Other 22

agency_id 1

  • FDA 22
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-0253-0019 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e7
FDA-2005-P-0253-0006 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442da
FDA-2005-P-0253-0005 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442d9
FDA-2005-P-0253-0013 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e1
FDA-2005-P-0253-0012 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e0
FDA-2005-P-0253-0021 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e9
FDA-2005-P-0253-0008 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442dc
FDA-2005-P-0253-0016 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e4
FDA-2005-P-0253-0009 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:03Z   0 0 09000064804442dd
FDA-2005-P-0253-0010 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442de
FDA-2005-P-0253-0017 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e5
FDA-2005-P-0253-0014 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e2
FDA-2005-P-0253-0015 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e3
FDA-2005-P-0253-0018 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e6
FDA-2005-P-0253-0020 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442e8
FDA-2005-P-0253-0011 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:03Z   0 0 09000064804442df
FDA-2005-P-0253-0007 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442db
FDA-2005-P-0253-0022 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 J. Shuren, Assistant Commissioner for Policy Other PDN-Petition Denial 2007-12-13T05:00:00Z 2007 12     2008-04-12T00:09:02Z   0 0 09000064804442ea
FDA-2005-P-0253-0004 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 HFM-1 to Simpson Woolley McConacnie, LLP Other LET-Letter 2006-03-14T05:00:00Z 2006 3     2008-04-12T00:09:03Z   0 0 09000064804442d5
FDA-2005-P-0253-0003 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 HFM-1 to Simpson Woolley McConachie L.L.P. Other LET-Letter 2005-10-31T05:00:00Z 2005 10     2008-04-12T00:09:02Z   0 0 09000064804442d1
FDA-2005-P-0253-0001 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 HFA-305 to Antibody Systems, Inc. Other ACK-Acknowledgement Letter 2005-05-12T04:00:00Z 2005 5     2008-04-12T00:09:02Z   0 0 090000648044429b
FDA-2005-P-0253-0002 FDA Withdraw April 14, 2003, Warning Letter, CBER 03-010, Addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA-CLOSED FDA-2005-P-0253 HFA-305 to Antibody Systems, Inc. Other ACK-Acknowledgement Letter 2005-05-12T04:00:00Z 2005 5     2008-04-12T00:09:02Z   0 0 09000064804442d0

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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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