documents

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

50 rows where agency_id = "FDA", document_type = "Rule" and posted_year = 2007 sorted by posted_date descending

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posted_year 1

  • 2007 · 50 ✖

document_type 1

  • Rule · 50 ✖

agency_id 1

  • FDA · 50 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-N-0379-0002 FDA FDA-2007-N-0379 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals Rule Direct Final Rule 2007-12-04T05:00:00Z 2007 12 2007-12-04T05:00:00Z 2008-02-20T04:59:59Z 2025-07-28T22:38:38Z E7-23294 0 0 090000648042c911
FDA-2007-0614-0002 FDA FDA-2007-0614 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals Rule Direct Final Rule 2007-12-04T05:00:00Z 2007 12 2007-12-04T05:00:00Z 2008-02-20T04:59:59Z 2015-12-07T15:14:43Z E7-23294 0 0 090000648036fb64
FDA-2006-E-0199-0009 FDA Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814 FDA-2006-E-0199 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Heller Ehrmann, LLP Rule Certificate Extending Patent Term 2007-10-23T04:00:00Z 2007 10     2025-12-15T18:32:37Z   0 0 0900006480450f22
FDA-2006-E-0436-0007 FDA Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243 FDA-2006-E-0436 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Cubist Pharmaceuticals, Inc. Rule Certificate Extending Patent Term 2007-10-23T04:00:00Z 2007 10     2025-12-17T10:00:23Z   0 0 0900006480461d88
FDA-2004-E-0397-0009 FDA Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937 FDA-2004-E-0397 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Burns, Doane, Swecker & Mathis, LLP Rule Certificate Extending Patent Term 2007-10-23T04:00:00Z 2007 10     2025-11-12T18:50:43Z   0 0 09000064804743e3
FDA-2000-E-0124-0006 FDA Patent Extension Alamast #5,034,230 FDA-2000-E-0124 Certificate Extending Patent Term from U.S. Patent and Trademark Office Rule Certificate Extending Patent Term 2007-10-23T04:00:00Z 2007 10     2025-07-22T20:28:07Z   0 0 09000064804cf446
FDA-2006-E-0319-0007 FDA Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818 FDA-2006-E-0319 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Foley & Lardner Rule Certificate Extending Patent Term 2007-10-23T04:00:00Z 2007 10     2025-12-18T20:19:20Z   0 0 090000648045cbc0
FDA-2006-E-0381-0008 FDA Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411 FDA-2006-E-0381 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Amylin Pharmaceuticals, Inc. Rule Certificate Extending Patent Term 2007-10-23T04:00:00Z 2007 10     2025-12-11T01:22:08Z   0 0 090000648046034f
FDA-2005-E-0311-0007 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Certificate Extending Patent Term from U.S. Patent and Trademark Office to OSI Pharmaceuticals, Inc. Rule Certificate Extending Patent Term 2007-10-17T04:00:00Z 2007 10     2025-12-03T10:00:20Z   0 0 0900006480447827
FDA-2003-E-0262-0006 FDA Patent Extension for Deramaxx (deracoxib), 5,521,207, Substituted Pyrazolyl Benzenesulfonamide for the treatment of inflammation FDA-2003-E-0262 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Pharmacia Corporation Rule Certificate Extending Patent Term 2007-10-17T04:00:00Z 2007 10     2025-10-23T23:42:31Z   0 0 090000648049048d
FDA-2004-N-0386-0003 FDA Food Labeling: Safe Handling Statements: Labeling of Shell Eggs FDA-2004-N-0386 Notice of Final Rule re Food Labeling: Safe Handling Statements: Labeling of Shell Eggs Rule Final Rule 2007-08-21T04:00:00Z 2007 8 2007-08-20T04:00:00Z   2016-01-13T20:03:22Z   0 0 0900006480474289
FDA-2005-N-0468-0003 FDA Designation of New Animal Drugs for Minor Uses or Minor Species-CLOSED FDA-2005-N-0468 Designation of New Animal Drugs for Minor Uses or Minor Species; Final Rule Rule Final Rule 2007-07-30T04:00:00Z 2007 7 2007-07-23T04:00:00Z   2016-01-12T19:25:22Z   0 0 0900006480450e1b
FDA-2005-H-0506-0096 FDA Civil Money Penalty: TMJ Implants, Inc. FDA-2005-H-0506 FDA/Administrative Law Judge Rule IDF-Initial Decision by Admin Law Judge 2007-07-06T04:00:00Z 2007 7     2008-04-11T23:48:24Z   0 0 09000064804646b4
FDA-1996-N-0028-0040 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 801-815) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T21:28:28Z   0 0 09000064804fbffd
FDA-1996-N-0028-0046 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 501-600) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T19:28:13Z   0 0 09000064804fc031
FDA-1996-N-0028-0047 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 601-700) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T19:32:45Z   0 0 09000064804fc036
FDA-1996-N-0028-0043 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 201-300) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T19:00:41Z   0 0 09000064804fc026
FDA-1996-N-0028-0045 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 401-500) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T19:23:23Z   0 0 09000064804fc02c
FDA-1996-N-0028-0041 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 1-100) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2011-06-11T16:25:44Z   0 0 09000064804fc01e
FDA-1996-N-0028-0039 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 701-800) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T19:36:59Z   0 0 09000064804fbff9
FDA-1996-N-0028-0044 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 301-400) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T19:02:46Z   0 0 09000064804fc029
FDA-1996-N-0028-0042 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 6/25/2007 - Notice of Final Rule (Pgs 101-200) Rule NFR-Notice of Final Rule 2007-06-27T04:00:00Z 2007 6 2007-06-22T04:00:00Z   2009-09-11T18:56:40Z   0 0 09000064804fc022
FDA-2007-N-0158-0001 FDA FDA-2007-N-0158 Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Rule Notice of Interim Rule 2007-06-25T04:00:00Z 2007 6 2007-06-25T04:00:00Z 2007-09-25T03:59:59Z 2025-07-18T09:00:23Z 07-3038 0 0 090000648042a483
FDA-1997-N-0067-0002 FDA Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling FDA-1997-N-0067 Notice of Final Rule re Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and, Related Labeling Rule Final Rule 2007-06-19T04:00:00Z 2007 6 2007-06-18T04:00:00Z   2015-11-17T15:32:27Z   0 0 09000064805d04ea
FDA-2006-E-0129-0006 FDA Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269 FDA-2006-E-0129 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Eli Lilly and Company Rule Certificate Extending Patent Term 2007-05-07T04:00:00Z 2007 5     2025-12-10T10:00:06Z   0 0 0900006480450277
FDA-2007-N-0222-0001 FDA FDA-2007-N-0222 Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System Rule Final Rule 2007-04-27T04:00:00Z 2007 4     2025-07-15T23:33:52Z E7-7702 0 0 090000648042ae10
FDA-2003-E-0062-0006 FDA Patent Term Restoration Application for Cypher sirolimus-eluting coronary stent, U.S. Patent No. 5,563,146 FDA-2003-E-0062 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Wyeth Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-10-29T19:41:10Z   0 0 0900006480481b11
FDA-2002-E-0120-0006 FDA Patent Application for Dutrasteride FDA-2002-E-0120 Letter from U.S. Patent and Trademark Office to GlaxoSmithKline Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-10-02T20:00:05Z   0 0 0900006480490324
FDA-2004-E-0142-0008 FDA Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333 FDA-2004-E-0142 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Roche Palo Alto Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-11-19T00:57:08Z   0 0 090000648046fe43
FDA-2006-E-0438-0008 FDA Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639 FDA-2006-E-0438 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Browdy and Neimark, P.L.L.C. Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-12-15T21:54:19Z   0 0 0900006480461e60
FDA-2004-E-0143-0007 FDA Patent Extension for ALIMTA (pemetrexed), U.S. Patent No. 5,344,932 FDA-2004-E-0143 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Eli Lilly and Company Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-11-12T17:44:00Z   0 0 090000648046fe53
FDA-2004-E-0201-0007 FDA Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382 FDA-2004-E-0201 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Abbott Laboratories Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-11-20T20:27:44Z   0 0 0900006480470be6
FDA-2001-E-0149-0003 FDA Patent Term Extension Application for Lotronex No. 5,360,800 FDA-2001-E-0149 U.S. Patent and Trademark Office to Glaxo Wellcome Inc. Rule CEP-Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2008-04-25T02:26:25Z   0 0 09000064804ddce0
FDA-2005-E-0361-0006 FDA Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667 FDA-2005-E-0361 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Buchanan Ingersol PC Rule Certificate Extending Patent Term 2007-04-23T04:00:00Z 2007 4     2025-12-03T21:46:45Z   0 0 090000648044aa3f
FDA-2004-E-0269-0019 FDA Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078 FDA-2004-E-0269 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Morgan Lewis & Bockius, LLP Rule Certificate Extending Patent Term 2007-04-20T04:00:00Z 2007 4     2025-11-18T19:18:37Z   0 0 090000648047220a
FDA-2005-E-0249-0008 FDA Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896 FDA-2005-E-0249 Certificate Extending Patent Term U.S. Patent and Trademark Office Rule Certificate Extending Patent Term 2007-04-20T04:00:00Z 2007 4     2025-12-03T20:37:50Z   0 0 09000064804441c8
FDA-2004-E-0199-0006 FDA Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958 FDA-2004-E-0199 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Sidley Austin Brown and Wood LLP Rule Certificate Extending Patent Term 2007-04-20T04:00:00Z 2007 4     2025-11-07T02:01:58Z   0 0 0900006480470bc3
FDA-2004-E-0082-0007 FDA Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491 FDA-2004-E-0082 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Sanofi-Aventis U.S., LLC Rule Certificate Extending Patent Term 2007-04-20T04:00:00Z 2007 4     2025-11-19T00:00:42Z   0 0 090000648046ede0
FDA-1976-N-0519-0009 FDA Over-the-Counter (OTC) General Comments & Combinations - OPEN FDA-1976-N-0519 Notice of Final Rule re Over-the-Counter (OTC) General Comments & Combinations Rule Final Rule 2007-03-19T04:00:00Z 2007 3 2007-03-16T04:00:00Z   2016-03-07T16:13:51Z   0 0 090000648053bd5c
FDA-2005-E-0250-0007 FDA Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890 FDA-2005-E-0250 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Novartis Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-12-02T20:44:38Z   0 0 0900006480444239
FDA-2003-E-0218-0007 FDA Patent Extension for Inspra (eplerenone), 4,559,332 FDA-2003-E-0218 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Pharmacia Corporation of Pfizer Inc Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-10-27T16:39:33Z   0 0 090000648048cb6b
FDA-2003-E-0461-0007 FDA Patent Extension, Velcade, bortezomib, #5,780,454 FDA-2003-E-0461 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Millennium Pharmaceuticals, Inc. Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-10-30T23:52:50Z   0 0 09000064804a290d
FDA-2003-E-0061-0008 FDA Patent Extension for Invanz (ertapenem sodium), 5,478,820 FDA-2003-E-0061 Certificate Extending Patent Term from U.S. Patent and Trademark Office from Merck & Co., Inc. Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-10-24T19:22:04Z   0 0 0900006480481af1
FDA-2003-E-0326-0008 FDA Patent Extension for Neotame, 5,480,668 FDA-2003-E-0326 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Fitzpatrick, Celia, Harper & Scinto Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-10-27T23:05:57Z   0 0 0900006480495882
FDA-2004-E-0079-0007 FDA Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate ) FDA-2004-E-0079 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Bristol-Myers Squibb Company Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-11-07T18:10:46Z   0 0 090000648046ed92
FDA-2002-E-0243-0003 FDA Patent Term Application for Zevalin No. 5,776,456 FDA-2002-E-0243 Letter from FDA CDER to Sidley Austin Brown and Wood LPP Rule Certificate Extending Patent Term 2007-03-15T04:00:00Z 2007 3     2025-10-08T00:02:56Z   0 0 090000648049a7ab
FDA-1998-E-0073-0009 FDA Patent Extension 4,490,351 VITREON FDA-1998-E-0073 Certificate Extending Patent Term Extension of US Patent No. 4,490,351 Rule Certificate Extending Patent Term 2007-02-06T05:00:00Z 2007 2     2025-03-05T18:23:55Z   0 0 0900006480583e38
FDA-1998-E-0073-0008 FDA Patent Extension 4,490,351 VITREON FDA-1998-E-0073 Certificate Extending Patent Term Extension of US Patent No. 4,490,351 Rule Certificate Extending Patent Term 2007-02-06T05:00:00Z 2007 2     2025-03-05T18:23:03Z   0 0 0900006480583e37
FDA-1999-E-0149-0003 FDA Patent Extension: Xoponex, levalbuterol hcl, #5,362,755 FDA-1999-E-0149 Certificate Extending Patent Term Rule Certificate Extending Patent Term 2007-02-06T00:00:00Z 2007 2     2025-05-13T22:26:00Z   0 0 09000064804af0f2
FDA-1999-E-0149-0004 FDA Patent Extension: Xoponex, levalbuterol hcl, #5,362,755 FDA-1999-E-0149 Certificate Extending Patent Term Rule Certificate Extending Patent Term 2007-02-06T00:00:00Z 2007 2     2025-05-13T22:27:14Z   0 0 09000064804af0f4

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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);