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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

607 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2008 sorted by posted_date descending

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posted_year 1

  • 2008 · 607 ✖

document_type 1

  • Notice · 607 ✖

agency_id 1

  • FDA · 607 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-N-0650-0001 FDA FDA-2008-N-0650 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z 2009-03-03T04:59:59Z 2024-11-12T04:27:47Z E8-31058 1 0 09000064808079b5
FDA-2007-N-0451-0005 FDA FDA-2007-N-0451 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2008-12-30T05:00:00Z 2008 12 2008-12-30T05:00:00Z   2008-12-30T13:05:40Z E8-31057 0 0 09000064808079a6
FDA-2008-N-0637-0001 FDA FDA-2008-N-0637 Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators Notice N-Notice 2008-12-29T05:00:00Z 2008 12 2008-12-29T05:00:00Z 2009-02-28T04:59:59Z 2024-11-12T04:27:44Z E8-30837 1 0 0900006480805ec3
FDA-2008-N-0652-0001 FDA FDA-2008-N-0652 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation Notice N-Notice 2008-12-29T05:00:00Z 2008 12 2008-12-29T05:00:00Z 2009-02-28T04:59:59Z 2024-11-12T04:27:11Z E8-30839 1 0 0900006480805e3a
FDA-2008-N-0045-0008 FDA FDA-2008-N-0045 Regulatory Site Visit Training Program; December 24, 2008 Notice N-Notice 2008-12-24T05:00:00Z 2008 12 2008-12-24T05:00:00Z 2009-01-24T04:59:59Z 2010-03-26T22:43:43Z E8-30659 0 0 09000064807f8e05
FDA-2004-D-0375-0019 FDA Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex FDA-2004-D-0375 Guidance for Industry and Food and Drug Administration Staff; ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability Notice NAD-Notice of Availability of Data 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T12:40:16Z E8-30586 0 0 09000064807eda05
FDA-2008-N-0644-0001 FDA FDA-2008-N-0644 SEQC--The Sequencing Quality Control Project Notice N-Notice 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T12:54:12Z E8-30410 0 0 09000064807eda32
FDA-2008-N-0648-0001 FDA FDA-2008-N-0648 Agency Information Collection Activities; Proposed Collection; Comment Request; PDUFA Pilot Project Proprietary Name Review Notice N-Notice 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z 2009-02-24T04:59:59Z 2008-12-23T12:59:23Z E8-30587 0 0 09000064807eda6f
FDA-1994-N-0182-0001 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Proposed Switch of Acyclovir from Prescription to Over-the-Counter Status; Public Hearing - Notice of Hearing Before the Commissioner Notice NHC-Notice of Hearing Before Commissioner 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z 1994-06-21T03:59:59Z 2008-12-23T21:00:51Z   0 0 0900006480507142
FDA-1994-N-0182-0002 FDA Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 Joint Meeting of the Antiviral Drugs and Nonprescription Drugs Advisory Committees - Notice of Meeting Notice NM-Notice of Meeting 2008-12-23T05:00:00Z 2008 12 2008-12-23T05:00:00Z   2008-12-23T21:00:52Z   0 0 0900006480507143
FDA-2008-D-0603-0001 FDA FDA-2008-D-0603 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability Notice NAD-Notice of Availability of Data 2008-12-22T05:00:00Z 2008 12 2008-12-22T05:00:00Z 2009-03-24T03:59:59Z 2008-12-22T13:00:05Z E8-30440 0 0 09000064807e6888
FDA-2004-D-0298-0004 FDA Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs, Availability FDA-2004-D-0298 Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date Notice NEC-Notice of Extension 2008-12-22T05:00:00Z 2008 12 2008-12-22T05:00:00Z   2008-12-22T12:52:04Z E8-30297 0 0 09000064807e6876
FDA-2008-N-0617-0001 FDA FDA-2008-N-0617 Determination That RUBRAMIN PC (Cyanocobalamin) Injection and Ten Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice N-Notice 2008-12-19T05:00:00Z 2008 12     2008-12-20T16:20:57Z E8-30154 0 0 09000064807e2d1a
FDA-2008-N-0641-0001 FDA FDA-2008-N-0641 Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments Notice N-Notice 2008-12-19T05:00:00Z 2008 12 2008-12-19T05:00:00Z 2009-02-18T04:59:59Z 2008-12-20T16:20:55Z E8-30278 0 0 09000064807e2d30
FDA-2008-N-0635-0001 FDA FDA-2008-N-0635 Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly "Emergency Medical Device Shortages Program Survey") Notice 60 Day Proposed Information Collection 2008-12-19T05:00:00Z 2008 12 2008-12-19T05:00:00Z 2009-02-18T04:59:59Z 2015-03-11T19:11:55Z E8-30155 0 0 09000064807e2d45
FDA-2008-N-0631-0001 FDA FDA-2008-N-0631 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority Notice N-Notice 2008-12-19T05:00:00Z 2008 12 2008-12-19T05:00:00Z 2009-02-18T04:59:59Z 2008-12-20T16:20:56Z E8-30280 0 0 09000064807e2c80
FDA-2008-D-0118-0028 FDA FDA-2008-D-0118 Guidance for Industry on Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability Notice NAD-Notice of Availability of Data 2008-12-19T05:00:00Z 2008 12 2008-12-19T05:00:00Z   2008-12-23T23:31:51Z E8-30086 0 0 09000064807e2c7c
FDA-2008-N-0613-0001 FDA FDA-2008-N-0613 Clinical Studies of Safety and Effectiveness of Orphan Products Notice   2008-12-18T05:00:00Z 2008 12 2008-12-18T05:00:00Z   2008-12-20T16:20:58Z E8-30061 0 0 09000064807e0637
FDA-2008-N-0039-0088 FDA FDA-2008-N-0039 New Animal Drugs; Tylosin Notice Notice of Final Rule 2008-12-18T05:00:00Z 2008 12     2013-07-11T14:42:33Z E8-29861 0 0 09000064807e0691
FDA-2008-N-0606-0001 FDA FDA-2008-N-0606 Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates Notice N-Notice 2008-12-17T05:00:00Z 2008 12 2008-12-17T05:00:00Z 2009-02-18T04:59:59Z 2008-12-20T16:20:59Z E8-29897 0 0 09000064807def85
FDA-2008-D-0623-0001 FDA FDA-2008-D-0623 Draft Guidance for Industry on Anesthetics for Companion Animals; Availability Notice NAD-Notice of Availability of Data 2008-12-17T05:00:00Z 2008 12 2008-12-17T05:00:00Z 2009-03-03T04:59:59Z 2008-12-20T16:30:41Z E8-29953 0 0 09000064807defce
FDA-2008-N-0439-0002 FDA FDA-2008-N-0439 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 Notice N-Notice 2008-12-17T05:00:00Z 2008 12     2008-12-20T16:22:36Z E8-29898 0 0 09000064807defa6
FDA-2008-N-0043-0016 FDA FDA-2008-N-0043 Memorandum of Understanding Between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration Notice N-Notice 2008-12-17T05:00:00Z 2008 12     2008-12-20T16:29:25Z E8-29952 0 0 09000064807df02f
FDA-2007-D-0365-0004 FDA FDA-2007-D-0365 Guidance for Industry on Orally Disintegrating Tablets; Availability Notice NAD-Notice of Availability of Data 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z   2008-12-21T02:35:44Z E8-29688 0 0 09000064807dd857
FDA-2008-N-0628-0002 FDA FDA-2008-N-0628 Microbiological Testing for Contact Lens Care Products; Public Workshop Notice NM-Notice of Meeting 2008-12-16T05:00:00Z 2008 12     2008-12-20T16:20:56Z E8-29741 0 0 09000064807dd7ce
FDA-2008-D-0626-0001 FDA FDA-2008-D-0626 Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability Notice NAD-Notice of Availability of Data 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z 2009-02-18T04:59:59Z 2009-01-23T17:39:34Z E8-29692 0 0 09000064807dd7fc
FDA-2008-D-0614-0001 FDA FDA-2008-D-0614 Draft Guidance for Industry on Changes to Approved New Animal Drug Applications--New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability Notice NAD-Notice of Availability of Data 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z 2009-02-18T04:59:59Z 2008-12-20T16:30:42Z E8-29691 0 0 09000064807dd83e
FDA-2008-D-0610-0001 FDA FDA-2008-D-0610 Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability Notice NAD-Notice of Availability of Data 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z 2009-02-18T04:59:59Z 2009-02-19T17:59:49Z   0 0 09000064807ddbf2
FDA-2008-N-0633-0001 FDA FDA-2008-N-0633 Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting Notice N-Notice 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z 2009-02-18T04:59:59Z 2008-12-20T16:20:56Z E8-29664 0 0 09000064807dd800
FDA-2008-N-0038-0092 FDA FDA-2008-N-0038 Advisory Committees; Filing of Closed Meeting Reports Notice N-Notice 2008-12-16T05:00:00Z 2008 12     2008-12-20T16:29:57Z E8-29679 0 0 09000064807dd802
FDA-2008-D-0629-0001 FDA FDA-2008-D-0629 Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability Notice NAD-Notice of Availability of Data 2008-12-16T05:00:00Z 2008 12 2008-02-15T05:00:00Z 2009-02-18T04:59:59Z 2009-02-13T13:25:56Z E8-29674 0 0 09000064807dd829
FDA-2008-N-0490-0004 FDA FDA-2008-N-0490 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program Notice N-Notice 2008-12-16T05:00:00Z 2008 12 2008-12-16T05:00:00Z   2008-12-20T16:21:40Z E8-29685 0 0 09000064807dd7c6
FDA-2008-N-0512-0003 FDA FDA-2008-N-0512 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices Notice N-Notice 2008-12-16T05:00:00Z 2008 12     2008-12-20T16:21:39Z E8-29672 0 0 09000064807dd87d
FDA-2008-N-0602-0001 FDA FDA-2008-N-0602 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits Notice N-Notice 2008-12-15T05:00:00Z 2008 12 2008-12-15T05:00:00Z 2009-02-14T04:59:59Z 2008-12-20T16:21:00Z E8-29517 0 0 09000064807dc0c0
FDA-2008-D-0611-0001 FDA FDA-2008-D-0611 Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability Notice NAD-Notice of Availability of Data 2008-12-12T05:00:00Z 2008 12 2008-12-12T05:00:00Z 2009-03-13T03:59:59Z 2009-03-19T21:37:24Z E8-29413 0 0 09000064807d8787
FDA-2008-N-0622-0001 FDA FDA-2008-N-0622 Withdrawal of Certain Proposed Rules and Other Proposed Actions Notice NWL-Notice of Withdrawl 2008-12-12T05:00:00Z 2008 12     2008-12-20T16:20:57Z E8-29331 0 0 09000064807d8820
FDA-2008-N-0499-0002 FDA FDA-2008-N-0499 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 Notice N-Notice 2008-12-12T05:00:00Z 2008 12     2008-12-20T16:21:40Z E8-29459 0 0 09000064807d87c4
FDA-2007-D-0429-0014 FDA FDA-2007-D-0429 Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability Notice Notice of Availability 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2019-08-20T11:52:24Z E8-29301 0 0 09000064807d7084
FDA-2007-D-0209-0016 FDA FDA-2007-D-0209 Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability Notice NAD-Notice of Availability of Data 2008-12-11T05:00:00Z 2008 12 2008-12-11T13:05:15Z   2008-12-21T02:36:15Z E8-29303 0 0 09000064807d6fbe
FDA-2008-N-0039-0086 FDA FDA-2008-N-0039 New Animal Drugs for Use in Animal Feeds; Ractopamine Notice Notice of Final Rule 2008-12-11T05:00:00Z 2008 12     2013-07-09T20:00:14Z E8-29177 0 0 09000064807d7057
FDA-2007-D-0025-0004 FDA FDA-2007-D-0025 Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval--the Premarket Approval Supplement Decisionmaking Process; Availability Notice NAD-Notice of Availability of Data 2008-12-11T05:00:00Z 2008 12 2008-12-11T12:59:15Z   2008-12-21T02:37:29Z E8-29330 0 0 09000064807d702e
FDA-2008-N-0038-0091 FDA FDA-2008-N-0038 Blood Products Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-12-09T05:00:00Z 2008 12 2008-12-09T05:00:00Z   2008-12-20T16:29:58Z E8-29105 0 0 09000064807d3c31
FDA-2008-N-0038-0090 FDA FDA-2008-N-0038 Risk Communication Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-12-08T05:00:00Z 2008 12 2008-12-08T05:00:00Z 2009-04-01T03:59:59Z 2009-02-24T19:58:08Z E8-28887 0 0 09000064807d1f6f
FDA-2008-N-0612-0001 FDA FDA-2008-N-0612 Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments Notice NM-Notice of Meeting 2008-12-05T05:00:00Z 2008 12 2008-12-05T16:46:01Z 2009-01-17T04:59:59Z 2008-12-20T16:20:58Z E8-28797 0 0 09000064807ce0bf
FDA-2008-N-0453-0002 FDA FDA-2008-N-0453 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act Notice 30 Day Proposed Information Collection 2008-12-04T05:00:00Z 2008 12     2015-03-16T20:38:23Z E8-28692 0 0 09000064807cc81a
FDA-2008-N-0043-0014 FDA FDA-2008-N-0043 Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC Notice N-Notice 2008-12-04T05:00:00Z 2008 12     2008-12-20T16:29:26Z E8-28690 0 0 09000064807cc834
FDA-2008-N-0454-0002 FDA FDA-2008-N-0454 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substances Notification System Notice N-Notice 2008-12-04T05:00:00Z 2008 12     2008-12-20T16:22:26Z E8-28694 0 0 09000064807cc7f7
FDA-2008-N-0607-0001 FDA FDA-2008-N-0607 Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices Notice N-Notice 2008-12-04T05:00:00Z 2008 12 2008-12-04T15:10:40Z 2009-02-03T04:59:59Z 2008-12-20T16:20:58Z E8-28695 0 0 09000064807cc7e6
FDA-1999-D-0128-0007 FDA Cooperative Manufacturing Arrangements for Licensed FDA-1999-D-0128 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability Notice NAD-Notice of Availability of Data 2008-12-04T05:00:00Z 2008 12 2008-12-04T15:06:23Z   2008-12-23T01:30:04Z E8-28693 0 0 09000064807cc7d2
FDA-2008-D-0609-0001 FDA FDA-2008-D-0609 Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability Notice NAD-Notice of Availability of Data 2008-12-03T05:00:00Z 2008 12 2008-12-03T05:00:00Z 2009-02-03T04:59:59Z 2008-12-31T12:14:33Z E8-28657 0 0 09000064807cac04
FDA-2008-D-0576-0001 FDA FDA-2008-D-0576 Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability Notice NAD-Notice of Availability of Data 2008-12-01T05:00:00Z 2008 12 2008-12-01T05:00:00Z   2024-11-12T04:25:37Z E8-28387 1 0 09000064807c7038
FDA-2008-N-0578-0004 FDA FDA-2008-N-0578 Pediatric Ethics Subcommittee; Amendment of Notice Notice N-Notice 2008-11-28T05:00:00Z 2008 11 2008-11-28T05:00:00Z   2008-12-20T16:21:02Z E8-28382 0 0 09000064807c39f6
FDA-2008-N-0595-0001 FDA FDA-2008-N-0595 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs Notice N-Notice 2008-11-26T05:00:00Z 2008 11 2008-11-26T05:00:00Z 2009-01-27T04:59:59Z 2008-12-20T16:21:01Z E8-28065 0 0 09000064807c1010
FDA-2008-D-0597-0001 FDA FDA-2008-D-0597 Draft Guidance for Industry: Small Entities Compliance Guide for Renderers--Substances Prohibited From Use in Animal Food or Feed; Availability Notice NAD-Notice of Availability of Data 2008-11-26T05:00:00Z 2008 11 2008-11-26T05:00:00Z 2009-01-27T04:59:59Z 2008-12-20T16:30:45Z E8-28189 0 0 09000064807c0fd7
FDA-2008-N-0162-0007 FDA FDA-2008-N-0162 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements Notice N-Notice 2008-11-26T05:00:00Z 2008 11 2008-11-26T05:00:00Z   2008-12-20T16:29:06Z E8-28064 0 0 09000064807c10cd
FDA-2008-N-0038-0089 FDA FDA-2008-N-0038 Sex Differences in the Cardiovascular Device Trials; Public Workshop Notice NM-Notice of Meeting 2008-11-26T05:00:00Z 2008 11 2008-11-26T05:00:00Z   2008-12-20T16:29:58Z E8-28169 0 0 09000064807c0fed
FDA-2008-D-0588-0001 FDA FDA-2008-D-0588 Compliance Policy Guide Sec. 540.700 Processed and/or Blended Seafood Products (CPG 7108.16); Availability Notice NAD-Notice of Availability of Data 2008-11-25T05:00:00Z 2008 11 2008-11-25T05:00:00Z   2020-05-14T17:56:30Z E8-27969 0 0 09000064807bf098
FDA-1999-N-2439-0003 FDA Public meeting/health & nutrient content claims in food lab FDA-1999-N-2439 FDA Notice NCR-Notice of Correction 2008-11-24T05:00:00Z 2008 11 2008-11-24T05:00:00Z   2008-11-24T20:55:54Z   0 0 09000064804f0462
FDA-1999-N-2439-0001 FDA Public meeting/health & nutrient content claims in food lab FDA-1999-N-2439 FDA Notice NM-Notice of Meeting 2008-11-24T05:00:00Z 2008 11 2008-11-24T05:00:00Z 1999-05-12T03:59:59Z 2008-11-24T20:52:32Z   0 0 09000064804f0461
FDA-2008-D-0592-0001 FDA FDA-2008-D-0592 Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability Notice NAD-Notice of Availability of Data 2008-11-24T05:00:00Z 2008 11 2008-11-24T05:00:00Z 2009-01-24T04:59:59Z 2009-01-27T18:39:41Z E8-27896 0 0 09000064807bd57c
FDA-2007-N-0474-0001 FDA FDA-2007-N-0474 Debarment Orders: George Kindness Notice NFR-Notice of Final Rule 2008-11-24T05:00:00Z 2008 11     2008-12-21T02:07:01Z E8-27802 0 0 09000064807bd6cd
FDA-2007-N-0488-0001 FDA FDA-2007-N-0488 Debarment Orders: Roy Page, M.D. Notice NFR-Notice of Final Rule 2008-11-24T05:00:00Z 2008 11     2008-12-21T02:06:53Z E8-27803 0 0 09000064807bd6b3
FDA-2008-N-0589-0001 FDA FDA-2008-N-0589 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mental Models Study of Health Care Providers Understanding of Prescription Drug Effectiveness Notice N-Notice 2008-11-24T05:00:00Z 2008 11 2008-11-24T05:00:00Z 2009-01-24T04:59:59Z 2008-12-20T16:21:01Z E8-27801 0 0 09000064807bd65b
FDA-2008-P-0029-0004 FDA FDA-2008-P-0029 Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice N-Notice 2008-11-21T05:00:00Z 2008 11     2008-12-20T16:20:55Z E8-27714 0 0 09000064807b6f10
FDA-2008-N-0038-0088 FDA FDA-2008-N-0038 Oncologic Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-11-21T05:00:00Z 2008 11     2008-12-20T16:29:58Z E8-27713 0 0 09000064807b6edc
FDA-1998-D-0560-0001 FDA Section 112 - Fast Track Products - FDAMA FDA-1998-D-0560 Food and Drug Administration Modernization Act of 1997; Establishment of Public Dockets; Section 112 Fast Track Products Notice N-Notice 2008-11-19T05:00:00Z 2008 11 2008-11-19T05:00:00Z   2008-11-20T00:17:45Z   0 0 090000648059b701
FDA-1998-D-0147-0001 FDA Section 118 Data Requirements for Drugs & Biologics, FDAMA FDA-1998-D-0147 Food and Drug Administration Modernization Act of 1997; Establishment of Public Dockets; Section 118 Data Requirements for Drugs & Biologics Notice N-Notice 2008-11-19T05:00:00Z 2008 11 2008-11-19T05:00:00Z   2008-11-19T23:21:40Z   0 0 090000648058a9ba
FDA-1998-D-0869-0001 FDA FDAMA Section 122 Radiopharmaceuticals FDA-1998-D-0869 Food and Drug Administration Modernization Act of 1997; Establishment of Public Dockets; Section 122 Radiopharmaceuticals Notice N-Notice 2008-11-19T05:00:00Z 2008 11 2008-11-19T05:00:00Z   2008-11-19T23:37:36Z   0 0 09000064805a1078
FDA-2008-N-0526-0001 FDA FDA-2008-N-0526 Global Harmonization Task Force, Study Group 1; Proposed Document Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer Notice NAD-Notice of Availability of Data 2008-11-19T05:00:00Z 2008 11 2008-11-19T05:00:00Z 2009-02-18T04:59:59Z 2009-02-19T14:23:14Z E8-27466 0 0 09000064807b1539
FDA-2008-N-0571-0001 FDA FDA-2008-N-0571 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicous Mark of Manufacturers on Single-Use Devices (formerly "Reprocessed Single-Use Device Labeling") Notice N-Notice 2008-11-18T05:00:00Z 2008 11 2008-11-18T05:00:00Z 2009-01-17T04:59:59Z 2024-11-12T04:25:39Z   1 0 09000064807b0083
FDA-2008-N-0038-0087 FDA FDA-2008-N-0038 Meetings: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Notice NM-Notice of Meeting 2008-11-18T05:00:00Z 2008 11 2008-11-18T05:00:00Z   2008-12-20T16:29:59Z E8-27255 0 0 09000064807af8df
FDA-2008-N-0397-0003 FDA FDA-2008-N-0397 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2008-11-18T05:00:00Z 2008 11 2008-11-18T05:00:00Z   2008-12-20T16:25:34Z E8-27258 0 0 09000064807af963
FDA-2008-D-0559-0001 FDA FDA-2008-D-0559 Industry on Process Validation, Draft Guidance; Availability: General Principles and Practices Notice NAD-Notice of Availability of Data 2008-11-18T05:00:00Z 2008 11 2008-11-18T05:00:00Z 2009-01-22T04:59:59Z 2009-01-27T19:14:18Z E8-27321 0 0 09000064807af91e
FDA-2008-E-0111-0006 FDA FDA-2008-E-0111 Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT Notice N-Notice 2008-11-18T05:00:00Z 2008 11 2008-11-18T05:00:00Z 2009-01-17T04:59:59Z 2024-11-07T22:00:28Z   1 0 09000064807b01d3
FDA-1978-N-1542-0043 FDA Whey, Whey Products & Hydrogen Peroxide FDA-1978-N-1542 GRAS Status of Whey, Whey Products & Hydrogen Peroxide Notice Notice of Final Rule 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2020-02-06T13:14:57Z 81-25547 0 0 090000648059bcd2
FDA-1978-N-1542-0047 FDA Whey, Whey Products & Hydrogen Peroxide FDA-1978-N-1542 GRAS Status of Whey, Whey Products & Hydrogen Peroxide; Correction Notice Correction 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2020-02-06T13:19:18Z 82-4294 0 0 090000648059bcd4
FDA-1978-N-1542-0029 FDA Whey, Whey Products & Hydrogen Peroxide FDA-1978-N-1542 Whey, Whey Products and Hydrogen Peroxide Affirmation of GRAS Status as Direct Human Food Ingredients; Extension of Comment Period Notice Notice of Extension 2008-11-16T05:00:00Z 2008 11 2008-11-16T05:00:00Z 1979-09-21T03:59:59Z 2020-04-08T16:31:10Z 79-28788 0 0 090000648059bcc5
FDA-1997-N-0398-0006 FDA Requirements for Refurbishers, Rebuilders, Remarketers Medic FDA-1997-N-0398 Medical Devices; Reconditioners, Rebuilder of Medical Devices; Revocation of Compliance Policy Guide; Request for Comments Notice N-Notice 2008-11-15T05:00:00Z 2008 11 2008-11-15T05:00:00Z   2008-11-15T22:07:17Z   0 0 09000064805d41ac
FDA-1998-P-0074-0007 FDA Grated Parmesan Cheese Deviating from Identity Standard FDA-1998-P-0074 Grated Parmesan Cheese Deviating From Identity Standard; Temporary Permit for Market Testing; Extension of Temporary Permit Notice NEC-Notice of Extension 2008-11-15T05:00:00Z 2008 11 2008-11-15T05:00:00Z   2011-08-01T17:25:04Z   0 0 0900006480583fae
FDA-1999-N-0083-0002 FDA Assessment of Preclinical Reproductive Toxicity Data FDA-1999-N-0083 FDA Notice NM-Notice of Meeting 2008-11-15T05:00:00Z 2008 11 2008-11-15T05:00:00Z   2008-11-15T19:48:37Z   0 0 09000064804a6983
FDA-1998-P-0074-0006 FDA Grated Parmesan Cheese Deviating from Identity Standard FDA-1998-P-0074 Grated Parmesan Cheese Deviating From Identity Standard; Temporary Permit for Market Testing Notice NTP-Notice of Temporary Permit 2008-11-15T05:00:00Z 2008 11 2008-11-15T05:00:00Z 1999-07-07T03:59:59Z 2008-11-15T18:59:08Z   0 0 0900006480583f64
FDA-2008-N-0578-0001 FDA FDA-2008-N-0578 Pediatric Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-11-14T05:00:00Z 2008 11 2008-11-14T05:00:00Z 2008-12-03T04:59:59Z 2008-11-14T13:23:05Z E8-27117 0 0 09000064807a8f23
FDA-2008-N-0578-0002 FDA FDA-2008-N-0578 Pediatric Ethics Subcommittee; Notice of Meeting Notice NM-Notice of Meeting 2008-11-14T05:00:00Z 2008 11 2008-11-14T05:00:00Z 2008-12-03T04:59:59Z 2008-11-28T12:54:30Z E8-27118 0 0 09000064807a8f45
FDA-2008-N-0038-0086 FDA FDA-2008-N-0038 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-11-13T05:00:00Z 2008 11     2008-11-13T13:09:39Z E8-26965 0 0 09000064807a6f2b
FDA-2008-N-0556-0001 FDA FDA-2008-N-0556 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products Notice 60 Day Proposed Information Collection 2008-11-13T05:00:00Z 2008 11 2008-11-13T05:00:00Z 2009-01-13T04:59:59Z 2015-02-20T23:02:32Z E8-27008 0 0 09000064807a6e8c
FDA-2008-N-0574-0001 FDA FDA-2008-N-0574 Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability Notice NAD-Notice of Availability of Data 2008-11-13T05:00:00Z 2008 11 2008-11-13T05:00:00Z 2009-01-13T04:59:59Z 2008-11-13T12:49:04Z E8-26869 0 0 09000064807a6ebe
FDA-2008-N-0581-0001 FDA FDA-2008-N-0581 Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees Notice N-Notice 2008-11-13T05:00:00Z 2008 11     2008-11-13T13:04:42Z E8-26963 0 0 09000064807a6f13
FDA-2004-P-0205-0016 FDA Vitamin D & Calcium & Reduced Risk of Osteoporosis FDA-2004-P-0205 Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis Notice NCR-Notice of Correction 2008-11-12T05:00:00Z 2008 11     2008-11-12T12:40:52Z E8-26868 0 0 09000064807a4d66
FDA-2008-N-0345-0004 FDA FDA-2008-N-0345 Agency Information Collection Activities; Proposals, Submissions, and Approvals Notice N-Notice 2008-11-12T05:00:00Z 2008 11     2008-11-12T13:34:49Z E8-26863 0 0 09000064807a4e21
FDA-2008-N-0039-0079 FDA FDA-2008-N-0039 Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets Notice Notice of Approval 2008-11-12T05:00:00Z 2008 11     2013-07-09T19:53:18Z E8-26793 0 0 09000064807a4da6
FDA-2004-D-0375-0018 FDA Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex FDA-2004-D-0375 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff; ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 Notice N-Notice 2008-11-10T05:00:00Z 2008 11 2008-11-10T05:00:00Z   2008-11-10T13:10:18Z E8-26828 0 0 09000064807a13df
FDA-2007-E-0229-0006 FDA FDA-2007-E-0229 Determination of Regulatory Review Period for Purposes of Patent Extension; TYKERB Notice N-Notice 2008-11-10T05:00:00Z 2008 11 2008-11-10T05:00:00Z 2009-01-10T04:59:59Z 2008-11-12T17:20:22Z E8-26679 0 0 09000064807a13a5
FDA-2008-E-0093-0006 FDA FDA-2008-E-0093 Determination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA Notice N-Notice 2008-11-10T05:00:00Z 2008 11 2008-11-10T05:00:00Z 2009-01-10T04:59:59Z 2008-11-10T13:02:42Z E8-26678 0 0 09000064807a13b2
FDA-2007-D-0487-0001 FDA FDA-2007-D-0487 Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Availability Notice NAD-Notice of Availability of Data 2008-11-07T05:00:00Z 2008 11 2008-11-07T05:00:00Z 2008-12-09T04:59:59Z 2008-11-10T20:55:06Z E8-26281 0 0 090000648079c492
FDA-2003-D-0435-0023 FDA Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 FDA-2003-D-0435 See FDA-2007-0487 Notice   2008-11-07T00:00:00Z 2008 11     2009-03-10T20:58:34Z   0 1 090000648079ca0a
FDA-2008-N-0567-0001 FDA FDA-2008-N-0567 Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing Notice NHC-Notice of Hearing Before Commissioner 2008-11-06T05:00:00Z 2008 11 2008-11-06T13:23:36Z 2009-02-07T04:59:59Z 2008-11-06T13:41:34Z E8-26528 0 0 0900006480797b39
FDA-2004-E-0081-0007 FDA Patent Term Extenstion Application for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402 FDA-2004-E-0081 Determination of Regulatory Review Period for Purposes of Patent Extension; S8 OVER-THE WIRE SYSTEM - Federal Register Notice Notice N-Notice 2008-11-06T05:00:00Z 2008 11 2008-11-06T05:00:00Z 2007-04-25T03:59:59Z 2008-11-06T12:58:48Z   0 0 090000648046edc8
FDA-1997-E-0063-0006 FDA Patent Term Extension Application for Reteplase; U.S. Patent No. 5,223,256 FDA-1997-E-0063 Determination of Review Period for Purposes of Patent Extenison - RETEVASE - Federal Register Notice Notice General Notice 2008-11-05T05:00:00Z 2008 11 2008-11-05T05:00:00Z 2007-05-30T03:59:59Z 2024-09-23T19:28:26Z   0 0 09000064805d033e
FDA-2008-N-0038-0083 FDA FDA-2008-N-0038 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-11-04T05:00:00Z 2008 11 2008-11-04T05:00:00Z   2008-11-04T13:45:13Z E8-26230 0 0 090000648079396e
FDA-2008-N-0038-0085 FDA FDA-2008-N-0038 Antiviral Drugs Advisory Committee; Notice of Meeting Notice NM-Notice of Meeting 2008-11-04T05:00:00Z 2008 11 2008-11-04T05:00:00Z   2008-11-04T13:55:29Z E8-26244 0 0 0900006480793998

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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);