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withdrawn,object_id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-2000-N-0108-0071,FDA,FDA-2000-N-0108,Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products: Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,Rule,Final Rule,2010-09-29T04:00:00Z,2010,9,2010-09-29T04:00:00Z,,2016-02-24T19:19:31Z,2010-24296,0,0,0900006480b63055
FDA-2000-N-0108-0075,FDA,FDA-2000-N-0108,"Reference 5.  U.S. Department of Commerce, Bureau of the Census, Economic Census, Manufacturing Industry Series  [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]",Supporting & Related Material,BKG-Background Material,2010-09-29T04:00:00Z,2010,9,,,2010-09-29T15:15:36Z,,0,0,0900006480b627cb
FDA-2000-N-0108-0074,FDA,FDA-2000-N-0108,"Reference 4.  Occupational Employment and Wage Estimates  May 2008  [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]",Supporting & Related Material,BKG-Background Material,2010-09-29T04:00:00Z,2010,9,,,2010-09-29T15:13:46Z,,0,0,0900006480b627c7
FDA-2000-N-0108-0072,FDA,FDA-2000-N-0108,"List of References re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule",Supporting & Related Material,List,2010-09-29T04:00:00Z,2010,9,,,2016-02-25T15:38:49Z,,0,0,0900006480b62025
FDA-2000-N-0108-0073,FDA,FDA-2000-N-0108,"Reference 1.  ""Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports Arising From Clinical Trials on Medicinal Products for Human Use"" [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]",Supporting & Related Material,BKG-Background Material,2010-09-29T04:00:00Z,2010,9,,,2010-09-29T15:03:54Z,,0,0,0900006480b62574
FDA-2000-N-0108-0076,FDA,FDA-2000-N-0108,"Reference 6.  U.S. Department of Commerce, Bureau of the Census, Economic Census, Manufacturing Industry Series, Biological Product Manufacturing, Table 4  [Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule]",Supporting & Related Material,BKG-Background Material,2010-09-29T04:00:00Z,2010,9,,,2010-09-29T15:16:51Z,,0,0,0900006480b62859
FDA-2000-N-0108-0054,FDA,FDA-2000-N-0108,Shipping Label re Comment from Teva Pharmaceutical Industries Ltd,Supporting & Related Material,Transmittals,2010-02-27T05:00:00Z,2010,2,,,2017-08-04T14:14:47Z,,0,0,09000064804c2776
FDA-2000-N-0108-0021,FDA,FDA-2000-N-0108,"Reference List - ""V.G. References"" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2017-08-11T13:34:03Z,,0,0,09000064804c26ba
FDA-2000-N-0108-0025,FDA,FDA-2000-N-0108,"Reference 15  - ""Agency for Health Care Policy and Research, “National Medical Expenditure Survey: Annual Expenses and Sources of Payment for Health Care Services, Research Findings 14,” p.7, 1995"" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2016-02-25T16:25:24Z,,0,0,09000064804c26ad
FDA-2000-N-0108-0024,FDA,FDA-2000-N-0108,"Reference 14 -""Statistical Abstract of the United States: The National Data Book, p.137-138, 1999"" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2017-08-11T15:01:33Z,,0,0,09000064804c26f5
FDA-2000-N-0108-0026,FDA,FDA-2000-N-0108,"Reference 17 - ""General Accounting Office, Adverse Drug Events The Magnitude of Health Risk Is Uncertain Because of Limited Incidence Data, GAO/HEHS-00-21, January, 2000"" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2016-02-25T16:29:36Z,,0,0,09000064804c26d1
FDA-2000-N-0108-0022,FDA,FDA-2000-N-0108,"Reference 10 - ""Institute of Medicine, edited by Kohn et al., To Err is Human: Building a Safer Health System, National Academy Press, 1999 "" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2016-02-25T16:35:18Z,,0,0,09000064804c26ed
FDA-2000-N-0108-0023,FDA,FDA-2000-N-0108,"Reference 12 - ""Department of Health and Human Services, Office of the Inspector General, Review of the Food and Drug Administration’s Handling of Adverse Drug Reaction Reports, Report No. A-15-98-50001, 1999"" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2016-02-25T16:35:47Z,,0,0,09000064804c26f1
FDA-2000-N-0108-0027,FDA,FDA-2000-N-0108,"Reference 25 - ""Eastern Research Group, Inc., “Cost of Implementing MedDRA Terminology for Pharmaceutical and Biologics Companies,”2000"" - [Safety Reporting Requirements for Human Drug and Biological Products; NPR1] re FDA-2000-N-0108-0006",Supporting & Related Material,Background Material,2010-02-26T05:00:00Z,2010,2,,,2016-02-25T16:54:58Z,,0,0,09000064804c26bc
FDA-2000-N-0108-0028,FDA,FDA-2000-N-0108,Comment from Bristol-Myers Squibb Pharmaceutical Research Institute,Other,Letter(s),2010-02-26T05:00:00Z,2010,2,2010-02-26T05:00:00Z,,2016-02-23T19:11:22Z,,0,0,09000064804c28fe