documents
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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Suggested facets: posted_month, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;