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

66 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 1997 sorted by posted_date descending

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posted_year 1

  • 1997 · 66 ✖

document_type 1

  • Notice · 66 ✖

agency_id 1

  • FDA · 66 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1992-N-0007-0004 FDA Draft Policy Statement of Scientific&Educational Activity FDA-1992-N-0007 FDA Notice NAD-Notice of Availability of Data 1997-12-02T05:00:00Z 1997 12     2008-05-16T23:31:45Z   0 0 0900006480525bec
FDA-1996-N-0052-0001 FDA Class/Reclass; Restricted Devices; Analyte Specific Reagents FDA-1996-N-0052 FDA Notice NFR-Notice of Final Rule 1997-11-28T05:00:00Z 1997 11     2008-05-16T22:17:40Z   0 0 09000064804fd270
FDA-1997-M-0021-0003 FDA Approval for implantable defilibrillators and programmers FDA-1997-M-0021 Background Material re Ventritex, Inc.; Premarket Approval of the TVL® Lead System Notice Notice of Approval 1997-11-20T05:00:00Z 1997 11 1997-11-20T05:00:00Z 1997-12-20T04:59:59Z 2024-11-27T13:22:23Z   0 0 09000064805ca10b
FDA-1997-M-0021-0002 FDA Approval for implantable defilibrillators and programmers FDA-1997-M-0021 Background Material re Ventritex, Inc.; Premarket Approval of the TVL® Lead System Notice Notice of Approval 1997-11-20T05:00:00Z 1997 11 1997-11-20T05:00:00Z 1997-12-20T04:59:59Z 2024-11-27T13:21:44Z   0 0 09000064805ca109
FDA-1997-M-0021-0001 FDA Approval for implantable defilibrillators and programmers FDA-1997-M-0021 Ventritex, Inc.; Premarket Approval of the TVL® Lead System Notice Notice of Approval 1997-11-20T05:00:00Z 1997 11 1997-11-20T05:00:00Z 1997-12-20T04:59:59Z 2024-11-27T13:20:25Z   0 0 09000064805ca107
FDA-1993-N-0043-0005 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 (COPY)- Expedited Safety Reporting Requirements for Human Drug and Biological Products Notice Notice of Final Rule 1997-10-09T04:00:00Z 1997 10 1997-10-09T04:00:00Z 1997-12-09T04:59:59Z 2024-04-29T15:09:23Z   0 0 09000064804fc456
FDA-1993-N-0043-0006 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 (COPY)- Expedited Safety Reporting Requirements for Human Drug and Biological Products Notice Notice of Final Rule 1997-10-09T04:00:00Z 1997 10 1997-10-09T04:00:00Z 1997-12-09T04:59:59Z 2024-04-29T15:10:12Z   0 0 09000064804fc457
FDA-1993-N-0043-0004 FDA Adverse Experience Reporting Requirements Drug/Biologicals FDA-1993-N-0043 Expedited Safety Reporting Requirements for Human Drug and Biological Products Notice Notice of Final Rule 1997-10-09T04:00:00Z 1997 10 1997-10-09T04:00:00Z 1997-12-09T04:59:59Z 2024-04-29T15:08:44Z   0 0 09000064804fc455
FDA-1995-N-0054-0003 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 FDA Notice NEC-Notice of Extension 1997-09-17T04:00:00Z 1997 9 1997-09-17T04:00:00Z 1997-12-03T04:59:59Z 2008-05-16T22:28:01Z   0 0 0900006480563bb8
FDA-1991-F-0039-0001 FDA Safe use of Silicone Acrylate Resins for coating FDA-1991-F-0039 Goldschmidt A. G. Notice NWL-Notice of Withdrawl 1997-09-12T04:00:00Z 1997 9     2008-05-16T23:37:58Z   0 0 090000648052a0c0
FDA-1989-N-0019-0002 FDA Prescription Labeling for Geriatric Use FDA-1989-N-0019 References from Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of "Geriatric Use" Subsection in the Labeling Notice Notice of Final Rule 1997-08-28T04:00:00Z 1997 8 1997-08-28T04:00:00Z 1997-10-30T04:59:59Z 2024-01-16T20:19:42Z   0 0 09000064804757c4
FDA-1989-N-0019-0001 FDA Prescription Labeling for Geriatric Use FDA-1989-N-0019 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of "Geriatric Use" Subsection in the Labeling Notice Notice of Final Rule 1997-08-28T04:00:00Z 1997 8 1997-08-28T04:00:00Z 1997-10-30T04:59:59Z 2024-01-17T02:00:08Z 97-22701 0 0 090000648047570f
FDA-1995-N-0054-0002 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 FDA Notice NPR-Notice of Proposed Rule-Making 1997-08-22T04:00:00Z 1997 8     2008-05-16T22:28:56Z   0 0 0900006480563a27
FDA-1997-N-0041-0001 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Prescription Drug Products; Levothyroxine Sodium Notice N-Notice 1997-08-20T04:00:00Z 1997 8 1997-08-20T04:00:00Z 1997-10-15T03:59:59Z 2009-01-24T19:53:02Z   0 0 09000064805cfc01
FDA-1997-N-0041-0002 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Prescription Drug Products; Levothyroxine Sodium [re FDA-1997-N-0041-0001 Notice N-Notice 1997-08-20T04:00:00Z 1997 8 1997-08-20T04:00:00Z 1997-10-15T03:59:59Z 2009-01-24T19:55:06Z   0 0 09000064805cfc03
FDA-1992-F-0035-0003 FDA 3-pentadecenyl phenol mixture FDA-1992-F-0035 Reference 3- Regarding Indirect Food Additives: Adhesives and Components of Coatings Notice Notice of Final Rule 1997-08-19T04:00:00Z 1997 8 1997-08-19T04:00:00Z 1997-09-12T03:59:59Z 2024-03-13T17:41:54Z   0 0 0900006480528697
FDA-1992-F-0035-0002 FDA 3-pentadecenyl phenol mixture FDA-1992-F-0035 Reference 1- Regarding Indirect Food Additives: Adhesives and Components of Coatings Notice Notice of Final Rule 1997-08-19T04:00:00Z 1997 8 1997-08-19T04:00:00Z 1997-09-12T03:59:59Z 2024-03-13T17:42:18Z   0 0 0900006480528696
FDA-1992-F-0035-0001 FDA 3-pentadecenyl phenol mixture FDA-1992-F-0035 Reference 2- Regarding Indirect Food Additives: Adhesives and Components of Coatings Notice Notice of Filing 1997-08-19T04:00:00Z 1997 8 1997-08-19T04:00:00Z 1997-09-12T03:59:59Z 2024-03-13T17:42:49Z   0 0 090000648052868b
FDA-1997-D-0048-0001 FDA Consumer-Directed Broadcast Advertisements FDA-1997-D-0048 Draft Guidance for Industry; Consumer-Directed Broadcast Advertisements; Availability Notice Notice of Data Availability 1997-08-18T04:00:00Z 1997 8 1997-08-18T04:00:00Z 1997-10-15T03:59:59Z 2024-01-26T02:01:04Z 97-21291 0 0 09000064805cfc9f
FDA-1997-N-0019-0021 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca03e
FDA-1997-N-0019-0022 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca03f
FDA-1997-N-0019-0008 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca031
FDA-1997-N-0019-0011 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca034
FDA-1997-N-0019-0016 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca039
FDA-1997-N-0019-0019 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca03c
FDA-1997-N-0019-0001 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca02a
FDA-1997-N-0019-0017 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca03a
FDA-1997-N-0019-0020 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca03d
FDA-1997-N-0019-0003 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca02c
FDA-1997-N-0019-0012 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca035
FDA-1997-N-0019-0002 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca02b
FDA-1997-N-0019-0006 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca02f
FDA-1997-N-0019-0014 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca037
FDA-1997-N-0019-0009 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca032
FDA-1997-N-0019-0013 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca036
FDA-1997-N-0019-0015 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca038
FDA-1997-N-0019-0004 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca02d
FDA-1997-N-0019-0007 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca030
FDA-1997-N-0019-0010 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:37Z   0 0 09000064805ca033
FDA-1997-N-0019-0018 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca03b
FDA-1997-N-0019-0005 FDA Conjugated Estrogens Tablets FDA-1997-N-0019 Duramed Pharm, Inc/Barr Labs., Inc Notice NPH-Notice of Opportunity of Hearing 1997-08-13T04:00:00Z 1997 8 1997-08-13T04:00:00Z 1997-09-09T03:59:59Z 2008-05-16T22:00:36Z   0 0 09000064805ca02e
FDA-1997-N-0058-0001 FDA Pregnancy Labeling; Content & Format Requirements FDA-1997-N-0058 FDA Notice NHC-Notice of Hearing Before Commissioner 1997-08-04T04:00:00Z 1997 8 1997-08-04T04:00:00Z 1997-11-13T04:59:59Z 2008-05-16T22:01:12Z   0 0 09000064805d0252
FDA-1997-N-0060-0001 FDA Feed mill license in accord with Animal Drug Avalblty Act FDA-1997-N-0060 Animal Drug Availability Act; Medicated Feed Mill Licenses Notice NPR-Notice of Proposed Rule-Making 1997-07-31T00:00:00Z 1997 7 1997-07-30T04:00:00Z 1997-10-29T04:59:59Z 2025-05-15T16:22:19Z 97-19820 0 0 09000064805d02f0
FDA-1997-M-0062-0001 FDA PMA of Prostar Percutaneous Vascular Surgical (PVS) System FDA-1997-M-0062 Perclose Inc. Notice NAL-Notice of Approval 1997-07-14T04:00:00Z 1997 7 1997-07-14T04:00:00Z 1997-08-08T03:59:59Z 2008-05-16T22:00:17Z   0 0 09000064805d0322
FDA-1995-N-0054-0001 FDA Ephedrine Alkaloids: Reports of Adverse Events; Availability FDA-1995-N-0054 FDA Notice NPR-Notice of Proposed Rule-Making 1997-06-06T04:00:00Z 1997 6 1997-06-06T04:00:00Z 1997-08-19T03:59:59Z 2008-05-16T22:32:03Z   0 0 090000648056205b
FDA-1996-D-0024-0002 FDA Clinical Safety Data Management: Safety Update Reports FDA-1996-D-0024 FDA Notice NAD-Notice of Availability of Data 1997-06-04T04:00:00Z 1997 6     2008-05-16T22:15:23Z   0 0 09000064804fa9b4
FDA-1996-D-0044-0002 FDA Stability Testing for New Dosage Forms, (ICH) FDA-1996-D-0044 FDA Notice NAD-Notice of Availability of Data 1997-05-15T04:00:00Z 1997 5     2008-05-16T22:15:25Z   0 0 09000064804fc65e
FDA-1996-N-0028-0006 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements FDA-1996-N-0028 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements - Notice of Extension of Comment Period Notice NEC-Notice of Extension 1997-05-12T04:00:00Z 1997 5 1997-05-12T04:00:00Z 1997-06-07T03:59:59Z 2009-09-24T19:41:36Z   0 0 09000064804fb83e
FDA-1996-P-0031-0001 FDA Consider solid oral dosage form drug products as same dosage-CLOSED FDA-1996-P-0031 FDA Notice N-Notice 1997-04-07T04:00:00Z 1997 4 1997-04-07T04:00:00Z 1997-06-27T03:59:59Z 2008-05-16T22:20:07Z   0 0 09000064804fc3de
FDA-1995-P-0002-0001 FDA Revise "Approved Drug Products" (known as "Orange Book")-CLOSED FDA-1995-P-0002 FDA Notice N-Notice 1997-04-07T04:00:00Z 1997 4 1997-04-07T04:00:00Z 1997-06-27T03:59:59Z 2008-05-16T23:06:16Z   0 0 0900006480558318
FDA-1997-D-0027-0001 FDA Providing Clinical Evidence of Effec. for Human Drugs & Biol FDA-1997-D-0027 FDA Notice NAD-Notice of Availability of Data 1997-04-07T04:00:00Z 1997 4 1997-04-07T04:00:00Z 1997-05-21T03:59:59Z 2008-05-16T21:59:18Z   0 0 09000064805ca326
FDA-1996-P-0016-0001 FDA Amend 'Healthy' Definition re: Sodium Levels FDA-1996-P-0016 FDA Notice NSA-Notice of Stay of Action 1997-04-02T05:00:00Z 1997 4 1997-04-02T05:00:00Z 1997-05-02T03:59:59Z 2008-05-16T22:19:41Z   0 0 09000064804f9dea
FDA-1992-S-0039-0001 FDA Public Docket to Provide Information on Submissions the Agency is Prepared to Accept Electronically FDA-1992-S-0039 Electronic Submissions; Establishment of Public Docket Notice N-Notice 1997-03-20T05:00:00Z 1997 3     2012-11-16T16:36:27Z Vol 62 No 54 0 0 090000648052882e
FDA-1996-E-0007-0001 FDA Patent Extension, Cerebyx, 4,260,769 FDA-1996-E-0007 Determination of Regulatory Review Period for Purposes of Patent Extension; CEREBYX® Notice General Notice 1997-03-20T05:00:00Z 1997 3 1997-03-20T05:00:00Z 1997-05-21T03:59:59Z 2024-09-16T16:54:52Z   0 0 09000064804f99e6
FDA-1992-N-0016-0001 FDA Electronic ID/Signatures; Electronic Records FDA-1992-N-0016 Electronic Records; Electronic Signatures Notice Notice of Final Rule 1997-03-20T05:00:00Z 1997 3 1997-03-20T05:00:00Z 1997-05-20T03:59:59Z 2024-03-30T01:00:44Z   0 0 0900006480526524
FDA-1992-N-0016-0002 FDA Electronic ID/Signatures; Electronic Records FDA-1992-N-0016 Electronic Records; Electronic Signatures Notice Notice of Final Rule 1997-03-20T05:00:00Z 1997 3 1997-03-20T05:00:00Z 1997-05-20T03:59:59Z 2024-03-29T13:24:17Z   0 0 090000648052672d
FDA-1995-N-0047-0003 FDA Well-Characterized Biotechnology Products; Eliminate License FDA-1995-N-0047 Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products; Correction Notice Correction 1997-03-18T05:00:00Z 1997 3 1997-03-13T05:00:00Z   2025-06-03T15:44:12Z 97-6359 0 0 09000064805616f0
FDA-1994-P-0043-0011 FDA Adopt Amendments Governing Health Claims & Nutrient Claims FDA-1994-P-0043 FDA Notice NEC-Notice of Extension 1997-03-14T05:00:00Z 1997 3 1997-03-14T05:00:00Z 1997-04-25T03:59:59Z 2008-05-16T23:21:19Z   0 0 09000064804ff4c1
FDA-1986-P-0023-0008 FDA Standards of Identity to Amend Certain Chocolate Products FDA-1986-P-0023 FDA Notice NPR-Notice of Proposed Rule-Making 1997-03-11T05:00:00Z 1997 3 1997-03-11T05:00:00Z 1997-05-28T03:59:59Z 2008-05-30T22:52:43Z   0 0 090000648050de93
FDA-1996-D-0012-0001 FDA Guidance on Labeling of Foods That Need Refrigeration by Consumers FDA-1996-D-0012 FDA Notice N-Notice 1997-02-27T05:00:00Z 1997 2     2008-05-16T22:15:21Z   0 0 09000064804f9b61
FDA-1996-N-0050-0002 FDA Regulations of Medical Foods FDA-1996-N-0050 FDA Notice NEC-Notice of Extension 1997-02-21T05:00:00Z 1997 2 1997-02-21T05:00:00Z 1997-04-29T03:59:59Z 2008-05-16T22:17:18Z   0 0 09000064804fc9bf
FDA-1997-N-0068-0001 FDA Adverse Event Reporting System for Postmarket Surveillance FDA-1997-N-0068 Review of the Adverse Event Reporting System for Postmarketing Surveillance; Public Meeting Notice Meeting 1997-02-21T00:00:00Z 1997 2 1997-02-20T05:00:00Z   2025-05-14T16:48:40Z 97-4161 0 0 09000064805d04f1
FDA-1996-D-0004-0003 FDA Designing Clinical Programs /drugs,devices,treatment of (RA) FDA-1996-D-0004 FDA Notice NM-Notice of Meeting 1997-02-03T05:00:00Z 1997 2     2008-05-16T22:15:17Z   0 0 09000064804f98f7
FDA-1994-P-0043-0003 FDA Adopt Amendments Governing Health Claims & Nutrient Claims FDA-1994-P-0043 FDA Notice NPR-Notice of Proposed Rule-Making 1997-01-29T05:00:00Z 1997 1 1997-01-29T05:00:00Z 1997-03-11T04:59:59Z 2008-05-16T23:21:15Z   0 0 09000064804ff4a4
FDA-1997-N-0059-0001 FDA Policy, Period of Market'g Exclusivity Prod w/Enantiomer Act FDA-1997-N-0059 Policy on Period of Marketing Exclusivity for Newly Approved Drug Products With Enantiomer Active Ingredients; Request for Comments Notice General Notice 1997-01-10T00:00:00Z 1997 1 1997-01-15T05:00:00Z 1997-03-18T04:59:59Z 2025-05-13T20:09:52Z 97-944 0 0 09000064805d02af
FDA-1996-M-0053-0001 FDA Premarket Approval of Emdogain FDA-1996-M-0053 Biora US, Inc.; Premarket Approval of EMDOGAIN® Notice Notice of Approval 1997-01-06T05:00:00Z 1997 1 1997-01-06T05:00:00Z 1996-12-24T04:59:59Z 2024-09-23T13:27:11Z   0 0 09000064804fd2be

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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;