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88 rows where docket_id = "FDA-1980-N-0049" sorted by posted_date descending
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document_type 4
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- FDA 88
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-1980-N-0049-0165 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information for Notice of Withdrawal of 12/29/04 - Tab 2: January 8, 2004, January 5, 2004, Biological Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Correction | Supporting & Related Material | Background Material | 2008-10-02T04:00:00Z | 2008 | 10 | 2020-05-22T16:57:55Z | 0 | 0 | 09000064805b9ac3 | |||
| FDA-1980-N-0049-0167 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information for Notice of Withdrawal of 12/29/04 - Tab 3: February 13, 2004, Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Correction | Supporting & Related Material | Background Material | 2008-10-02T04:00:00Z | 2008 | 10 | 2020-05-22T17:18:00Z | 0 | 0 | 09000064805b9ac5 | |||
| FDA-1980-N-0049-0166 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information for Notice of Withdrawal of 12/29/04 - Tab 1: January 5, 2004, Biological Products; Bacterial Vaccines and Toxoids; Implementaiton of Efficacy Review; Final rule and final order | Supporting & Related Material | Background Material | 2008-10-02T04:00:00Z | 2008 | 10 | 2020-05-22T17:01:18Z | 0 | 0 | 09000064805b9ac4 | |||
| FDA-1980-N-0049-0164 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information for Notice of Withdrawal of 12/29/04 - Tab 4: October 27, 2004, Court issued a memorandum opinion vacating and remanding the January 2004 final rule and final order to FDA for reconsideration | Supporting & Related Material | Background Material | 2008-10-02T04:00:00Z | 2008 | 10 | 2020-05-22T16:55:09Z | 0 | 0 | 09000064805b9ac2 | |||
| FDA-1980-N-0049-0163 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Notice | Notice of Final Rule | 2005-12-21T05:00:00Z | 2005 | 12 | 2005-12-15T05:00:00Z | 2020-09-25T13:40:57Z | 05-24224 | 0 | 0 | 09000064805ba0aa | |
| FDA-1980-N-0049-0162 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Notice | General Notice | 2005-12-21T05:00:00Z | 2005 | 12 | 2005-12-15T05:00:00Z | 2020-09-25T13:43:01Z | 05-24223 | 0 | 0 | 09000064805ba0a9 | |
| FDA-1980-N-0049-0124 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T17:26:17Z | 0 | 0 | 09000064805ba082 | |||
| FDA-1980-N-0049-0142 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:47:53Z | 0 | 0 | 09000064805ba095 | |||
| FDA-1980-N-0049-0144 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T13:18:41Z | 0 | 0 | 09000064805ba097 | |||
| FDA-1980-N-0049-0146 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:08:05Z | 0 | 0 | 09000064805ba099 | |||
| FDA-1980-N-0049-0156 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T19:47:03Z | 0 | 0 | 09000064805ba0a3 | |||
| FDA-1980-N-0049-0137 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:46:44Z | 0 | 0 | 09000064805ba08f | |||
| FDA-1980-N-0049-0155 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:24:38Z | 0 | 0 | 09000064805ba0a2 | |||
| FDA-1980-N-0049-0157 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:45:00Z | 0 | 0 | 09000064805ba0a4 | |||
| FDA-1980-N-0049-0127 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T17:41:35Z | 0 | 0 | 09000064805ba085 | |||
| FDA-1980-N-0049-0154 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:21:37Z | 0 | 0 | 09000064805ba0a1 | |||
| FDA-1980-N-0049-0141 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T21:02:42Z | 0 | 0 | 09000064805ba093 | |||
| FDA-1980-N-0049-0139 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:47:11Z | 0 | 0 | 09000064805ba091 | |||
| FDA-1980-N-0049-0149 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T13:37:37Z | 0 | 0 | 09000064805ba09c | |||
| FDA-1980-N-0049-0159 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:49:10Z | 0 | 0 | 09000064805ba0a6 | |||
| FDA-1980-N-0049-0126 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T17:37:32Z | 0 | 0 | 09000064805ba084 | |||
| FDA-1980-N-0049-0130 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:44:46Z | 0 | 0 | 09000064805ba088 | |||
| FDA-1980-N-0049-0132 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T19:44:09Z | 0 | 0 | 09000064805ba08a | |||
| FDA-1980-N-0049-0134 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T20:02:28Z | 0 | 0 | 09000064805ba08c | |||
| FDA-1980-N-0049-0138 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:46:59Z | 0 | 0 | 09000064805ba090 | |||
| FDA-1980-N-0049-0148 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T13:31:39Z | 0 | 0 | 09000064805ba09b | |||
| FDA-1980-N-0049-0129 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T18:54:03Z | 0 | 0 | 09000064805ba087 | |||
| FDA-1980-N-0049-0143 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T13:14:43Z | 0 | 0 | 09000064805ba096 | |||
| FDA-1980-N-0049-0151 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T19:51:46Z | 0 | 0 | 09000064805ba09e | |||
| FDA-1980-N-0049-0153 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:17:12Z | 0 | 0 | 09000064805ba0a0 | |||
| FDA-1980-N-0049-0136 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T20:14:58Z | 0 | 0 | 09000064805ba08e | |||
| FDA-1980-N-0049-0150 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T19:50:51Z | 0 | 0 | 09000064805ba09d | |||
| FDA-1980-N-0049-0125 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T17:32:47Z | 0 | 0 | 09000064805ba083 | |||
| FDA-1980-N-0049-0152 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T19:52:41Z | 0 | 0 | 09000064805ba09f | |||
| FDA-1980-N-0049-0158 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:33:57Z | 0 | 0 | 09000064805ba0a5 | |||
| FDA-1980-N-0049-0160 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:52:22Z | 0 | 0 | 09000064805ba0a7 | |||
| FDA-1980-N-0049-0131 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:45:11Z | 0 | 0 | 09000064805ba089 | |||
| FDA-1980-N-0049-0133 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T19:47:40Z | 0 | 0 | 09000064805ba08b | |||
| FDA-1980-N-0049-0147 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T13:28:39Z | 0 | 0 | 09000064805ba09a | |||
| FDA-1980-N-0049-0135 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T20:10:43Z | 0 | 0 | 09000064805ba08d | |||
| FDA-1980-N-0049-0145 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T13:24:03Z | 0 | 0 | 09000064805ba098 | |||
| FDA-1980-N-0049-0161 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review (Non-AVA); Final Rule and Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-09T20:55:12Z | 0 | 0 | 09000064805ba0a8 | |||
| FDA-1980-N-0049-0128 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-10T18:38:53Z | 0 | 0 | 09000064805ba086 | |||
| FDA-1980-N-0049-0140 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Background Information re Biological Products; Bacterial Vaccines and Toxiods; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Supporting & Related Material | Background Material | 2005-12-15T05:00:00Z | 2005 | 12 | 2020-09-15T14:47:29Z | 0 | 0 | 09000064805ba092 | |||
| FDA-1980-N-0049-0116 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Letter from Russell E. Dingle and Thomas L. Rempfer to FDA re: Electronic Comment from Mr. Lawrence Rizzo | Supporting & Related Material | Background Material | 2005-04-13T04:00:00Z | 2005 | 4 | 2020-05-27T13:02:20Z | 0 | 0 | 09000064805b9bf0 | |||
| FDA-1980-N-0049-0118 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Letter from Russell E. Dingle and Thomas L. Rempfer to FDA re: Electronic Comment from Mr. Lawrence Rizzo | Supporting & Related Material | Background Material | 2005-04-13T04:00:00Z | 2005 | 4 | 2020-05-27T13:02:11Z | 0 | 0 | 09000064805b9bf2 | |||
| FDA-1980-N-0049-0120 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Letter from David Panzera to FDA/DDM re: Electronic Comment from Mr. David Panzera | Supporting & Related Material | Background Material | 2005-04-13T04:00:00Z | 2005 | 4 | 2020-05-27T13:12:21Z | 0 | 0 | 09000064805b9bf5 | |||
| FDA-1980-N-0049-0119 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Letter from David Panzera to FDA/DDM re: Electronic Comment from Mr. David Panzera | Supporting & Related Material | Background Material | 2005-04-13T04:00:00Z | 2005 | 4 | 2020-05-27T13:12:31Z | 0 | 0 | 09000064805b9bf4 | |||
| FDA-1980-N-0049-0115 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Letter from US Army Medical Research Institute of Infectious Disease to FDA/DDM re: Electronic Comment from US Army Medical Research Institute of Infectious Disease | Supporting & Related Material | Background Material | 2005-04-13T04:00:00Z | 2005 | 4 | 2020-05-27T12:51:31Z | 0 | 0 | 09000064805b9bef | |||
| FDA-1980-N-0049-0106 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | HFM-17 | Other | CR-Correction | 2005-03-04T05:00:00Z | 2005 | 3 | 2008-05-30T22:52:24Z | 0 | 0 | 09000064805b9aee | |||
| FDA-1980-N-0049-0105 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | HFM-17 | Other | CR-Correction | 2005-03-04T05:00:00Z | 2005 | 3 | 2008-05-30T22:53:08Z | 0 | 0 | 09000064805b9aed | |||
| FDA-1980-N-0049-0096 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2005-01-06T05:00:00Z | 2005 | 1 | 2004-12-23T05:00:00Z | 2005-03-30T04:59:59Z | 2020-05-11T14:23:43Z | 04-28322 | 0 | 0 | 09000064805b99fc |
| FDA-1980-N-0049-0095 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal | Notice | Withdrawal | 2005-01-06T05:00:00Z | 2005 | 1 | 2004-12-23T05:00:00Z | 2020-05-11T14:00:29Z | 04-28459 | 0 | 0 | 09000064805b99fb | |
| FDA-1980-N-0049-0093 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal | Notice | Withdrawal | 2005-01-06T05:00:00Z | 2005 | 1 | 2004-12-23T05:00:00Z | 2020-05-11T13:58:41Z | 04-28459 | 0 | 0 | 09000064805b99f9 | |
| FDA-1980-N-0049-0094 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal | Notice | Withdrawal | 2005-01-06T05:00:00Z | 2005 | 1 | 2004-12-23T05:00:00Z | 2020-05-11T13:58:58Z | 04-28459 | 0 | 0 | 09000064805b99fa | |
| FDA-1980-N-0049-0088 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Other | Report | 2004-12-27T05:00:00Z | 2004 | 12 | 2020-05-21T12:41:00Z | 0 | 0 | 09000064805b99f4 | |||
| FDA-1980-N-0049-0091 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Other | Report | 2004-12-27T05:00:00Z | 2004 | 12 | 2020-05-21T12:51:32Z | 0 | 0 | 09000064805b99f7 | |||
| FDA-1980-N-0049-0089 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Other | Report | 2004-12-27T05:00:00Z | 2004 | 12 | 2020-05-21T12:44:51Z | 0 | 0 | 09000064805b99f5 | |||
| FDA-1980-N-0049-0087 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Other | Report | 2004-12-27T05:00:00Z | 2004 | 12 | 2020-05-21T12:27:53Z | 0 | 0 | 09000064805b99f3 | |||
| FDA-1980-N-0049-0092 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Other | Report | 2004-12-27T05:00:00Z | 2004 | 12 | 2020-05-21T12:56:57Z | 0 | 0 | 09000064805b99f8 | |||
| FDA-1980-N-0049-0090 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Other | Report | 2004-12-27T05:00:00Z | 2004 | 12 | 2020-05-21T12:47:47Z | 0 | 0 | 09000064805b99f6 | |||
| FDA-1980-N-0049-0086 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction | Notice | Correction | 2004-02-20T05:00:00Z | 2004 | 2 | 2004-02-13T05:00:00Z | 2020-05-12T12:44:15Z | 04-3135 | 0 | 0 | 09000064805b99de | |
| FDA-1980-N-0049-0085 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction | Notice | Correction | 2004-02-20T05:00:00Z | 2004 | 2 | 2004-02-13T05:00:00Z | 2020-05-11T13:47:13Z | 04-3135 | 0 | 0 | 09000064805b99dd | |
| FDA-1980-N-0049-0062 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Draft: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Notice | Notice of Final Rule | 2004-01-17T05:00:00Z | 2004 | 1 | 2003-12-30T05:00:00Z | 2020-05-11T13:30:40Z | 03-32255 | 0 | 0 | 09000064805b99c6 | |
| FDA-1980-N-0049-0061 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Notice | Notice of Final Rule | 2004-01-17T05:00:00Z | 2004 | 1 | 2003-12-30T05:00:00Z | 2020-05-11T13:28:17Z | 03-32255 | 0 | 0 | 09000064805b99c5 | |
| FDA-1980-N-0049-0060 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Notice | Notice of Final Rule | 2004-01-17T05:00:00Z | 2004 | 1 | 2003-12-30T05:00:00Z | 2020-05-12T12:38:34Z | 03-32255 | 0 | 0 | 09000064805b99c4 | |
| FDA-1980-N-0049-0067 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 19: http://www.fda.gov/cber/gdlns/leverhnbk.pdf | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:42:07Z | 0 | 0 | 09000064805b99cb | |||
| FDA-1980-N-0049-0077 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 12: "Protecting our Kids: What is causing the current shortage in childhood vaccines? Testimony Before the Committee on Governmental Affairs, United States Senate," June 12, 2002," http://www. cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002. htm | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T18:58:35Z | 0 | 0 | 09000064805b99d5 | |||
| FDA-1980-N-0049-0065 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 18: http://www.fda.gov/ohrms//dockets/ac/02/transcripts/3842t1.pdf | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:53:55Z | 0 | 0 | 09000064805b99c9 | |||
| FDA-1980-N-0049-0068 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 16: http://www.fda. gov/ohrms/dockets/ac/01/transcripts/3805t2_01 .pdf | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:31:09Z | 0 | 0 | 09000064805b99cc | |||
| FDA-1980-N-0049-0074 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 6: Anthrax Vaccine Adsorbed (BIOTHRAX) Package Insert (January 31, 2002) | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T16:51:25Z | 0 | 0 | 09000064805b99d2 | |||
| FDA-1980-N-0049-0079 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference List | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T16:09:59Z | 0 | 0 | 09000064805b99d7 | |||
| FDA-1980-N-0049-0080 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 14: Centers for Disease Control and Prevention,"Prevention of Plague: Recommendations of the Advisory Committee on Immunization Practices (ACIP)," Morbidity and Mortality Weekly Report, 45 (No. RR-14), 1996 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T18:49:26Z | 0 | 0 | 09000064805b99d8 | |||
| FDA-1980-N-0049-0070 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 10: "Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)," September 1998, http://www.fda.gov/cber/gdlns/vaers-1.pdf | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:17:27Z | 0 | 0 | 09000064805b99ce | |||
| FDA-1980-N-0049-0084 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html. | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T19:30:18Z | 0 | 0 | 09000064805b99dc | |||
| FDA-1980-N-0049-0063 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 11: "Estimated Vaccination Coverage with 3+DTP Among Children 19-35 Months of Age by Race/Ethnicity, and by State and Immunization Action Plan Area - U.S., National Immunization Survey, Q3/2000 - Q2/2001," http://www.cdc.gov/nip/coverage/NlS/00-01/tab19- 3dpt_race_iap. htm. | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T19:21:05Z | 0 | 0 | 09000064805b99c7 | |||
| FDA-1980-N-0049-0076 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html. | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T16:40:29Z | 0 | 0 | 09000064805b99d4 | |||
| FDA-1980-N-0049-0083 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 3: Fellows, P. F., M. K. Linscott, B. E. Ivins, M. L. M. Pitt, C. A. Rossi, P. H. Gibbs, and A. M. Friedlander, "Efficacy of a Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin," Vaccine, 19(23-24):3241-3247, 2001 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T18:23:42Z | 0 | 0 | 09000064805b99db | |||
| FDA-1980-N-0049-0081 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 2: Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, http://www. nap. edu/catalog/10310. html. | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T16:41:44Z | 0 | 0 | 09000064805b99d9 | |||
| FDA-1980-N-0049-0082 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 4: Ivins, B. E., P. F. Fellows, M. L. M. Pitt, J. E. Estep, S. L. Welkos, P. L.Worsham and A. M. Friedlander, "Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys," Salisbury Medical Bulletin 87(Suppl.):125-126, 1996 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T18:30:13Z | 0 | 0 | 09000064805b99da | |||
| FDA-1980-N-0049-0073 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 7: Wright, G. G., Green, T. W, and Kanode, Jr., R. G., "Studies on Immunity in Anthrax: V. Immunizing Activity of Alum-Precipitated Protective Antigen," Journal of Immunology, 73:387- 391, 1954 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T16:57:23Z | 0 | 0 | 09000064805b99d1 | |||
| FDA-1980-N-0049-0075 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 1: Brachman, P. S., H. Gold, S. Plotkin, F. R. Fekety, M. Werrin, and N. R. Ingraham, "Field Evaluation of a Human Anthrax Vaccine," American Journal of Public Health, 52:632-645, 1962. | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T16:42:28Z | 0 | 0 | 09000064805b99d3 | |||
| FDA-1980-N-0049-0064 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 9: "Table of Reportable Events Following Vaccination," http://www.vaers.org/reportable.htm. | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T19:11:53Z | 0 | 0 | 09000064805b99c8 | |||
| FDA-1980-N-0049-0071 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 13: Colditz, et al., "Efficacy of BCG Vaccine in the Prevention of Tuberculosis: Meta Analysis of the Published Literature," Journal of the American Medical Association, 271:698-702, 1994 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:09:06Z | 0 | 0 | 09000064805b99cf | |||
| FDA-1980-N-0049-0066 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Transcript in the matter of Vaccines and Related Biological Products Advisory Committee | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-20T16:17:24Z | 0 | 0 | 09000064805b99ca | |||
| FDA-1980-N-0049-0069 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 15: http://Mrww.fda.gov/ohrms/dockets/ac/01/transcripts/3755t1.pdf | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:26:38Z | 0 | 0 | 09000064805b99cd | |||
| FDA-1980-N-0049-0078 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 5: Ivins, B. E., M. L. M. Pitt, P. F. Fellows, J. W. Farchaus, B. E. Benner, D. M. Waag, S. F. Little, G. W. Anderson, P. H. Gibbs, and A. M. Friedlander, "Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques," Vaccine, 16(11-12):1141-1148,1998 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T18:42:51Z | 0 | 0 | 09000064805b99d6 | |||
| FDA-1980-N-0049-0072 | FDA | Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 | Reference 8: 61 FR 40153, August 1, 1996 | Supporting & Related Material | Background Material | 2003-12-29T05:00:00Z | 2003 | 12 | 2020-05-19T17:01:43Z | 0 | 0 | 09000064805b99d0 |
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