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1,443 rows where docket_id = "FDA-2015-N-0101" sorted by posted_date descending
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document_type 4
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agency_id 1
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2015-N-0101-1505 | FDA | None FDA-2015-N-0101 | Response Letter from FDA CDER to American Cleaning Institute | Other | Letter(s) | 2025-06-13T04:00:00Z | 2025 | 6 | 2025-06-13T04:00:00Z | 2025-06-13T19:01:10Z | 0 | 0 | 09000064b8e0622c | ||
| FDA-2015-N-0101-1504 | FDA | None FDA-2015-N-0101 | Response Letter from FDA CDER to Cardinal Health | Other | Letter(s) | 2025-06-13T04:00:00Z | 2025 | 6 | 2025-06-13T04:00:00Z | 2025-06-13T19:01:02Z | 0 | 0 | 09000064b8e0622a | ||
| FDA-2015-N-0101-1503 | FDA | None FDA-2015-N-0101 | Meeting Minutes 05/09/18 – Benzalkonium chloride and benzethonium chloride | Other | Minutes | 2023-02-17T05:00:00Z | 2023 | 2 | 2023-02-17T05:00:00Z | 2023-02-17T15:18:05Z | 0 | 0 | 09000064856b008c | ||
| FDA-2015-N-0101-1502 | FDA | None FDA-2015-N-0101 | FINAL Third Extension Deferral Letter | Other | Letter(s) | 2022-05-31T04:00:00Z | 2022 | 5 | 2022-05-31T04:00:00Z | 2022-05-31T14:52:21Z | 0 | 0 | 0900006483e573e0 | ||
| FDA-2015-N-0101-1498 | FDA | None FDA-2015-N-0101 | FDA Extension Deferral Letter from FDA CDER to Cardinal Health | Other | Letter(s) | 2021-04-08T04:00:00Z | 2021 | 4 | 2021-04-08T04:00:00Z | 2021-04-08T15:54:51Z | 0 | 0 | 0900006484aa01b4 | ||
| FDA-2015-N-0101-1497 | FDA | None FDA-2015-N-0101 | Meeting Request and Briefing Document Benzethonium Chloride (BZT) - In Vivo Efficacy | Other | Brief | 2020-12-10T05:00:00Z | 2020 | 12 | 2020-12-10T05:00:00Z | 2020-12-10T17:39:34Z | 0 | 0 | 09000064849960ea | ||
| FDA-2015-N-0101-1496 | FDA | None FDA-2015-N-0101 | America Cleaning Institute Meeting Request Cover Letter - BZT Efficacy | Other | Letter(s) | 2020-12-10T05:00:00Z | 2020 | 12 | 2020-12-10T05:00:00Z | 2020-12-10T17:39:21Z | 0 | 0 | 09000064849960e8 | ||
| FDA-2015-N-0101-1495 | FDA | None FDA-2015-N-0101 | The American CIeaning Institute Progress Report | Other | Report | 2020-12-04T05:00:00Z | 2020 | 12 | 2020-12-04T05:00:00Z | 2020-12-04T16:06:56Z | 0 | 0 | 0900006484986dcc | ||
| FDA-2015-N-0101-1494 | FDA | None FDA-2015-N-0101 | FDA Updated Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi) | Other | Letter(s) | 2020-11-23T05:00:00Z | 2020 | 11 | 2020-11-23T05:00:00Z | 2020-11-23T13:06:06Z | 0 | 0 | 0900006484970494 | ||
| FDA-2015-N-0101-1493 | FDA | None FDA-2015-N-0101 | FDA Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi) | Other | Agency Response | 2020-11-20T05:00:00Z | 2020 | 11 | 2020-11-20T05:00:00Z | 2020-11-20T14:38:10Z | 0 | 0 | 090000648496ca60 | ||
| FDA-2015-N-0101-1492 | FDA | None FDA-2015-N-0101 | ACI Advice November 18 2020 | Other | Letter(s) | 2020-11-20T05:00:00Z | 2020 | 11 | 2020-11-20T05:00:00Z | 2020-11-20T14:33:15Z | 0 | 0 | 090000648496c580 | ||
| FDA-2015-N-0101-1490 | FDA | None FDA-2015-N-0101 | Request for Extension from Cardinal Health | Other | Request for Extension | 2020-10-19T04:00:00Z | 2020 | 10 | 2020-10-19T04:00:00Z | 2020-10-19T14:58:37Z | 0 | 0 | 09000064849112cd | ||
| FDA-2015-N-0101-1489 | FDA | None FDA-2015-N-0101 | ACI BZT Monograph Meeting Minutes Written Responses | Supporting & Related Material | Meeting Materials | 2020-10-06T04:00:00Z | 2020 | 10 | 2020-10-06T14:57:14Z | 0 | 0 | 09000064848de17f | |||
| FDA-2015-N-0101-1491 | FDA | None FDA-2015-N-0101 | Advice Letter from FDA CDER to ACI Advice Povidone-Iodine-SP | Other | Letter(s) | 2020-09-30T04:00:00Z | 2020 | 9 | 2020-05-27T04:00:00Z | 2020-10-19T21:03:50Z | 0 | 0 | 0900006484918e18 | ||
| FDA-2015-N-0101-1487 | FDA | None FDA-2015-N-0101 | FINAL Third Extension Deferral Letter from FDA CDER to American Cleaning Institute | Other | Letter(s) | 2019-10-17T04:00:00Z | 2019 | 10 | 2019-10-17T04:00:00Z | 2019-10-17T15:37:24Z | 0 | 0 | 09000064840b4534 | ||
| FDA-2015-N-0101-1485 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Cardinal Health | Other | Letter(s) | 2019-10-10T04:00:00Z | 2019 | 10 | 2019-10-10T04:00:00Z | 2019-10-10T20:32:21Z | 0 | 0 | 090000648407ecdf | ||
| FDA-2015-N-0101-1486 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Cardinal Health | Other | Letter(s) | 2019-10-10T04:00:00Z | 2019 | 10 | 2019-10-10T04:00:00Z | 2019-10-10T20:44:43Z | 0 | 0 | 090000648407ece2 | ||
| FDA-2015-N-0101-1484 | FDA | None FDA-2015-N-0101 | Report from American Chemistry Council | Other | Report | 2019-09-13T04:00:00Z | 2019 | 9 | 2019-09-13T04:00:00Z | 2019-09-13T19:44:23Z | 0 | 0 | 0900006483f377cf | ||
| FDA-2015-N-0101-1482 | FDA | None FDA-2015-N-0101 | ACI FINAL Advice Letter re MARCH 7 2019 Submission | Other | Letter(s) | 2019-08-29T04:00:00Z | 2019 | 8 | 2019-08-29T04:00:00Z | 2019-08-29T15:18:50Z | 0 | 0 | 0900006483ed93e3 | ||
| FDA-2015-N-0101-1478 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute (ACI) part 1 of 4 | Other | Report | 2019-08-09T04:00:00Z | 2019 | 8 | 2019-08-09T04:00:00Z | 2019-08-09T14:01:36Z | 0 | 0 | 0900006483e17457 | ||
| FDA-2015-N-0101-1476 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Cardinal Health | Other | Letter(s) | 2019-08-09T04:00:00Z | 2019 | 8 | 2019-08-09T04:00:00Z | 2019-08-09T12:53:53Z | 0 | 0 | 0900006483e1e010 | ||
| FDA-2015-N-0101-1477 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to American Cleaning Institute | Other | Letter(s) | 2019-08-09T04:00:00Z | 2019 | 8 | 2019-08-09T04:00:00Z | 2019-08-09T12:55:36Z | 0 | 0 | 0900006483e1e016 | ||
| FDA-2015-N-0101-1480 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute (ACI) part 3 of 4 | Other | Report | 2019-08-09T04:00:00Z | 2019 | 8 | 2019-08-09T04:00:00Z | 2019-08-09T15:44:35Z | 0 | 0 | 0900006483e17b71 | ||
| FDA-2015-N-0101-1479 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute (ACI) part 2 of 4 | Other | Report | 2019-08-09T04:00:00Z | 2019 | 8 | 2019-08-09T04:00:00Z | 2019-08-09T14:47:35Z | 0 | 0 | 0900006483e17a11 | ||
| FDA-2015-N-0101-1481 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute (ACI) part 4 of 4 | Other | Report | 2019-08-09T04:00:00Z | 2019 | 8 | 2019-08-09T04:00:00Z | 2019-08-09T16:06:49Z | 0 | 0 | 0900006483e17e57 | ||
| FDA-2015-N-0101-1475 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to American Cleaning Institute | Other | Letter(s) | 2019-07-15T04:00:00Z | 2019 | 7 | 2019-07-15T04:00:00Z | 2019-07-15T18:44:01Z | 0 | 0 | 0900006483d91e22 | ||
| FDA-2015-N-0101-1473 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Cardinal Health | Other | Letter(s) | 2019-07-03T04:00:00Z | 2019 | 7 | 2019-07-03T04:00:00Z | 2019-07-03T12:02:44Z | 0 | 0 | 0900006483d5b379 | ||
| FDA-2015-N-0101-1471 | FDA | None FDA-2015-N-0101 | Cardinal Health Meeting Minutes | Other | Minutes | 2019-05-21T04:00:00Z | 2019 | 5 | 2019-05-21T04:00:00Z | 2019-05-21T11:13:18Z | 0 | 0 | 0900006483ca7399 | ||
| FDA-2015-N-0101-1470 | FDA | None FDA-2015-N-0101 | Request for Extension from Cardinal Health | Other | Request for Extension | 2019-04-16T04:00:00Z | 2019 | 4 | 2019-04-16T04:00:00Z | 2019-04-16T16:21:39Z | 0 | 0 | 0900006483ba8c32 | ||
| FDA-2015-N-0101-1468 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Ciba Specialty Chemicals Corporation | Other | Letter(s) | 2019-04-11T04:00:00Z | 2019 | 4 | 2019-04-11T04:00:00Z | 2019-04-11T16:42:14Z | 0 | 0 | 0900006483b85637 | ||
| FDA-2015-N-0101-1466 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Ciba Specialty Chemicals Corporation | Other | Letter(s) | 2019-04-11T04:00:00Z | 2019 | 4 | 2019-04-11T04:00:00Z | 2019-04-11T16:36:33Z | 0 | 0 | 0900006483b8558f | ||
| FDA-2015-N-0101-1467 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to Bayer Corporation | Other | Letter(s) | 2019-04-11T04:00:00Z | 2019 | 4 | 2019-04-11T04:00:00Z | 2019-04-11T16:39:49Z | 0 | 0 | 0900006483b85632 | ||
| FDA-2015-N-0101-1465 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute (ACI) | Other | Report | 2019-03-13T04:00:00Z | 2019 | 3 | 2019-03-13T04:00:00Z | 2019-03-13T20:49:19Z | 0 | 0 | 0900006483ad853f | ||
| FDA-2015-N-0101-1464 | FDA | None FDA-2015-N-0101 | Letter from FDA CDER to CARDINAL HEALTH | Other | Letter(s) | 2019-03-04T05:00:00Z | 2019 | 3 | 2019-03-04T05:00:00Z | 2019-03-04T17:47:56Z | 0 | 0 | 0900006483abbf02 | ||
| FDA-2015-N-0101-1463 | FDA | None FDA-2015-N-0101 | Meeting Granted Letter from FDA CDER to Cardinal Health | Other | Approval | 2018-12-31T05:00:00Z | 2018 | 12 | 2018-12-31T05:00:00Z | 2018-12-31T22:18:50Z | 0 | 0 | 09000064839d240f | ||
| FDA-2015-N-0101-1462 | FDA | None FDA-2015-N-0101 | Letter from CardinalHealth | Other | Letter(s) | 2018-11-23T05:00:00Z | 2018 | 11 | 2018-11-23T05:00:00Z | 2018-11-23T18:03:40Z | 0 | 0 | 090000648385a622 | ||
| FDA-2015-N-0101-1460 | FDA | None FDA-2015-N-0101 | Report from Cardinal Health part 3 of 4 | Other | Report | 2018-11-19T05:00:00Z | 2018 | 11 | 2018-11-19T05:00:00Z | 2018-11-19T17:14:42Z | 0 | 0 | 09000064838e3c72 | ||
| FDA-2015-N-0101-1461 | FDA | None FDA-2015-N-0101 | Report from Cardinal Health part 4 of 4 | Other | Report | 2018-11-19T05:00:00Z | 2018 | 11 | 2018-11-19T05:00:00Z | 2018-11-19T17:17:51Z | 0 | 0 | 09000064838e3c93 | ||
| FDA-2015-N-0101-1458 | FDA | None FDA-2015-N-0101 | Report from Cardinal Health part 1 of 4 | Other | Report | 2018-11-19T05:00:00Z | 2018 | 11 | 2018-11-19T05:00:00Z | 2018-11-19T17:13:11Z | 0 | 0 | 09000064838e3c5b | ||
| FDA-2015-N-0101-1459 | FDA | None FDA-2015-N-0101 | Report from Cardinal Health part 2 of 4 | Other | Report | 2018-11-19T05:00:00Z | 2018 | 11 | 2018-11-19T05:00:00Z | 2018-11-19T17:15:16Z | 0 | 0 | 09000064838e3c60 | ||
| FDA-2015-N-0101-1456 | FDA | None FDA-2015-N-0101 | Response from FDA CDER to American Cleaning Institute | Other | Agency Response | 2018-08-07T04:00:00Z | 2018 | 8 | 2018-08-07T04:00:00Z | 2018-08-07T19:23:21Z | 0 | 0 | 09000064835e728a | ||
| FDA-2015-N-0101-1455 | FDA | None FDA-2015-N-0101 | American Chemistry Council FINAL letter July 25 2018 | Other | Agency Response | 2018-07-25T04:00:00Z | 2018 | 7 | 2018-07-25T04:00:00Z | 2018-07-25T13:54:20Z | 0 | 0 | 0900006483555882 | ||
| FDA-2015-N-0101-1454 | FDA | None FDA-2015-N-0101 | FDA CDER FINAL Advice Letter - ACI Final Report Time-Kill Study-2 | Other | Response(s) | 2018-07-06T04:00:00Z | 2018 | 7 | 2018-07-06T04:00:00Z | 2018-07-06T11:42:16Z | 0 | 0 | 09000064834b08d3 | ||
| FDA-2015-N-0101-1453 | FDA | None FDA-2015-N-0101 | Supplement from American Chemistry Council | Other | Supplement (SUP) | 2018-05-23T04:00:00Z | 2018 | 5 | 2018-05-23T04:00:00Z | 2018-05-23T20:41:08Z | 0 | 0 | 09000064832a2c55 | ||
| FDA-2015-N-0101-1452 | FDA | None FDA-2015-N-0101 | Meeting Granted Letter 05/09/2018 | Other | Letter(s) | 2018-04-23T04:00:00Z | 2018 | 4 | 2018-04-23T04:00:00Z | 2018-04-23T15:11:41Z | 0 | 0 | 09000064831aa877 | ||
| FDA-2015-N-0101-1451 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute | Other | Report | 2018-04-17T04:00:00Z | 2018 | 4 | 2018-04-17T04:00:00Z | 2018-04-17T20:51:06Z | 0 | 0 | 0900006483136056 | ||
| FDA-2015-N-0101-1450 | FDA | None FDA-2015-N-0101 | Grant of Second Extension April 12_2018 | Other | Extension of Time | 2018-04-16T04:00:00Z | 2018 | 4 | 2018-04-16T04:00:00Z | 2018-04-16T14:59:47Z | 0 | 0 | 0900006483146ff2 | ||
| FDA-2015-N-0101-1449 | FDA | None FDA-2015-N-0101 | Final Validation Reports (Bionanalysis Report) from Lonza Inc., and Henkel Consumer Goods, Inc., (Lewis & Harrison) | Other | Report | 2018-04-11T04:00:00Z | 2018 | 4 | 2018-04-11T04:00:00Z | 2018-04-11T20:11:00Z | 0 | 0 | 09000064831182c1 | ||
| FDA-2015-N-0101-1448 | FDA | None FDA-2015-N-0101 | Briefing Documents from Lonza Inc., and Henkel Consumer Goods, Inc., (Lewis & Harrison) | Other | Studies | 2018-04-11T04:00:00Z | 2018 | 4 | 2018-04-11T04:00:00Z | 2018-04-11T19:59:30Z | 0 | 0 | 09000064831174b0 | ||
| FDA-2015-N-0101-1447 | FDA | None FDA-2015-N-0101 | MEETING MINUTES - ETOH Monograph Meeting | Other | Letter(s) | 2018-03-30T04:00:00Z | 2018 | 3 | 2018-03-30T04:00:00Z | 2018-03-30T15:25:34Z | 0 | 0 | 0900006483074aca | ||
| FDA-2015-N-0101-1446 | FDA | None FDA-2015-N-0101 | Report from American Cleaning Institute | Other | Report | 2018-03-05T05:00:00Z | 2018 | 3 | 2018-03-05T05:00:00Z | 2018-03-05T15:47:32Z | 0 | 0 | 0900006482f6401f | ||
| FDA-2015-N-0101-1445 | FDA | None FDA-2015-N-0101 | Supplement from Richard Sedlak | Other | Supplement (SUP) | 2018-02-22T05:00:00Z | 2018 | 2 | 2018-02-22T05:00:00Z | 2018-02-22T19:57:51Z | 0 | 0 | 0900006482f53515 | ||
| FDA-2015-N-0101-1444 | FDA | None FDA-2015-N-0101 | Meeting Granted Letter ACI020818 | Other | Letter(s) | 2018-02-14T05:00:00Z | 2018 | 2 | 2018-02-14T05:00:00Z | 2018-02-14T16:08:54Z | 0 | 0 | 0900006482f31647 | ||
| FDA-2015-N-0101-1442 | FDA | None FDA-2015-N-0101 | Letter from American Cleaning Institute | Other | Letter(s) | 2018-02-09T05:00:00Z | 2018 | 2 | 2018-02-09T05:00:00Z | 2018-02-09T15:38:54Z | 0 | 0 | 0900006482ef8532 | ||
| FDA-2015-N-0101-1443 | FDA | None FDA-2015-N-0101 | Request for Meeting from Lonza Inc. and Henkel Consumer Goods, Inc. (Lewis & Harrison) | Other | Request | 2018-02-09T05:00:00Z | 2018 | 2 | 2018-02-09T05:00:00Z | 2018-02-09T16:20:44Z | 0 | 0 | 0900006482f07041 | ||
| FDA-2015-N-0101-1440 | FDA | None FDA-2015-N-0101 | Letter from FDA to American Cleaning Institute | Other | Letter(s) | 2018-02-08T05:00:00Z | 2018 | 2 | 2018-02-08T05:00:00Z | 2018-02-08T16:52:52Z | 0 | 0 | 0900006482f00f2d | ||
| FDA-2015-N-0101-1441 | FDA | None FDA-2015-N-0101 | Meeting Materials from The American Cleaning Institute | Other | Meeting Exhibits | 2018-02-08T05:00:00Z | 2018 | 2 | 2018-02-08T05:00:00Z | 2018-02-08T21:00:46Z | 0 | 0 | 0900006482f0252a | ||
| FDA-2015-N-0101-1384 | FDA | None FDA-2015-N-0101 | 033 Reference 22 - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Industry. The need for Carcinogenicity Studies re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:06:57Z | 0 | 0 | 0900006482cea5a1 | |||
| FDA-2015-N-0101-1388 | FDA | None FDA-2015-N-0101 | 037 Reference 26 - Guidance for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:09:27Z | 0 | 0 | 0900006482cea5a5 | |||
| FDA-2015-N-0101-1376 | FDA | None FDA-2015-N-0101 | 025 Reference 14 - FDA_Letter_regarding_Deferral_of_Isopropyl_Alcohol re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:59:34Z | 0 | 0 | 0900006482cea90f | |||
| FDA-2015-N-0101-1377 | FDA | None FDA-2015-N-0101 | 026 Reference 15 - FDA_Letter_regarding_Deferral_of_Povidone_Iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:00:28Z | 0 | 0 | 0900006482cea910 | |||
| FDA-2015-N-0101-1378 | FDA | None FDA-2015-N-0101 | 027 Reference 16 - Wheelock and Lookinland, Effect of surgical hand scrub time on subsequent bacterial growth re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:01:26Z | 0 | 0 | 0900006482cea911 | |||
| FDA-2015-N-0101-1399 | FDA | None FDA-2015-N-0101 | 048 Reference 37 - Sivaji et al 1986 Disinfectant Induced Changes in the Antibiotic Sensitivity and Phage Typing Pattern in S aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:17:42Z | 0 | 0 | 0900006482cea5b0 | |||
| FDA-2015-N-0101-1402 | FDA | None FDA-2015-N-0101 | 051 Reference 40 - Kunisada et al, Investigation on the efficacy of povidone-iodine against antiseptic-resistant species re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:19:37Z | 0 | 0 | 0900006482cea5b3 | |||
| FDA-2015-N-0101-1412 | FDA | None FDA-2015-N-0101 | 063 Reference 52 - Kawamura-Sato et al, Correlation between Reduced Susceptibility to Disinfectants and Multidrug Resistance among Clinical Isolates of Acinetobacter Species re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:27:44Z | 0 | 0 | 0900006482cea7c9 | |||
| FDA-2015-N-0101-1417 | FDA | None FDA-2015-N-0101 | 068 Reference 57 - Wiegand et al, Analysis of the Adaptation Capacity of Staphylococcus Aureus to Commonly Used Antiseptics by Microplate Laser Nephelometry re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:31:48Z | 0 | 0 | 0900006482cea7ce | |||
| FDA-2015-N-0101-1369 | FDA | None FDA-2015-N-0101 | 018 Reference 7 - CDC, Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:52:56Z | 0 | 0 | 0900006482cea908 | |||
| FDA-2015-N-0101-1375 | FDA | None FDA-2015-N-0101 | 024 Reference 13 - FDA_Letter_regarding_Deferral_of_Ethyl_Alcohol re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:58:37Z | 0 | 0 | 0900006482cea90e | |||
| FDA-2015-N-0101-1386 | FDA | None FDA-2015-N-0101 | 035 Reference 24 - FDA, Redbook 2000 IV.C.9.a Reproduction and Developmental Toxicity Studies Guidelines for Reproduction Studies re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:08:17Z | 0 | 0 | 0900006482cea5a3 | |||
| FDA-2015-N-0101-1364 | FDA | None FDA-2015-N-0101 | 013 Reference 2 -12 - Volume_IX_9_of_9_Published_Cited_References_Part_2_of_2_re_C12 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:48:33Z | 0 | 0 | 0900006482cea4c0 | |||
| FDA-2015-N-0101-1382 | FDA | None FDA-2015-N-0101 | 031 Reference 20 - Phenolphthalein Exposure Causes Multiple Carcinogenic Effects in Experimental Model Systems re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:05:34Z | 0 | 0 | 0900006482cea915 | |||
| FDA-2015-N-0101-1408 | FDA | None FDA-2015-N-0101 | 059 Reference 48 - Weber et al, Use of germicides in the home and the healthcare setting re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:24:53Z | 0 | 0 | 0900006482cea5ba | |||
| FDA-2015-N-0101-1371 | FDA | None FDA-2015-N-0101 | 020 Reference 9 - Innovations in Health Care- Antisepsis as a Case Study re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:55:17Z | 0 | 0 | 0900006482cea90a | |||
| FDA-2015-N-0101-1351 | FDA | None FDA-2015-N-0101 | Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Rule | Final Rule | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T05:00:00Z | 2017-12-20T14:10:12Z | 2017-27317 | 0 | 0 | 0900006482d3e4e3 | |
| FDA-2015-N-0101-1355 | FDA | None FDA-2015-N-0101 | 003 Reference 2 -2 - Volume_II_2_of_9_Feedback_Meeting_and_Working_Texts_From_the_Feedback_Meeting_March_29_1995_Attachment_1_through_6_re_Comment_from_Soap_Deter re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:40:41Z | 0 | 0 | 0900006482ce9f70 | |||
| FDA-2015-N-0101-1359 | FDA | None FDA-2015-N-0101 | 007 Reference 2 -6 - Volume_V_5_of_9_References_Continuation_re_Comment_from_Soap_Detergent_Association_(SDA) re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:43:42Z | 0 | 0 | 0900006482cea4ba | |||
| FDA-2015-N-0101-1362 | FDA | None FDA-2015-N-0101 | 010 Reference 2 -9 - Volume_VII_7_of_9_References_Continuation_re_C12 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:46:40Z | 0 | 0 | 0900006482cea4bd | |||
| FDA-2015-N-0101-1391 | FDA | None FDA-2015-N-0101 | 040 Reference 29 - Novel Water-Based Antiseptic Lotion Demonstrates Rapid, Broad-Spectrum Kill Compared with Alcohol Antiseptic re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:11:44Z | 0 | 0 | 0900006482cea5a8 | |||
| FDA-2015-N-0101-1395 | FDA | None FDA-2015-N-0101 | 044 Reference 33 - Bactericidal Activity of Antiseptics against Methicillin-Resistant Staphylococcus Aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:14:42Z | 0 | 0 | 0900006482cea5ac | |||
| FDA-2015-N-0101-1398 | FDA | None FDA-2015-N-0101 | 047 Reference 36 - Sivaji and Mandal 1987 Antibiotic Resistance and Serotypic Variations in E coli Induced by Disinfectants re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:17:10Z | 0 | 0 | 0900006482cea5af | |||
| FDA-2015-N-0101-1406 | FDA | None FDA-2015-N-0101 | 056 Reference 45 - Ghasemzadeh-Moghaddam et al, Methicillin-Susceptible and -Resistant Staphylococcus Aureus with High-Level Antiseptic re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:22:32Z | 0 | 0 | 0900006482cea5b7 | |||
| FDA-2015-N-0101-1372 | FDA | None FDA-2015-N-0101 | 021 Reference 10 - FDA_Letter_regarding_Deferral_of_Benzalkonium_Chloride re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:56:00Z | 0 | 0 | 0900006482cea90b | |||
| FDA-2015-N-0101-1422 | FDA | None FDA-2015-N-0101 | 073 Reference 62 - Barry et al, Lack of Effect of Antibiotic Resistance on Susceptibility of Microorganisms to Chlorhexidine Gluconate or Povidone Iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:37:21Z | 0 | 0 | 0900006482ceabe2 | |||
| FDA-2015-N-0101-1434 | FDA | None FDA-2015-N-0101 | 085 Reference 74 - Copitch et al, Prevalence of decreased susceptibility to triclosan in Salmonella enterica isolates from animals and humans and association with multiple re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:42:47Z | 0 | 0 | 0900006482ceabee | |||
| FDA-2015-N-0101-1437 | FDA | None FDA-2015-N-0101 | 088 Reference 77 - Joynson et al, Adaptive Resistance to Benzalkonium Chloride, Amikacin and Tobramycin re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:44:09Z | 0 | 0 | 0900006482ceabf1 | |||
| FDA-2015-N-0101-1390 | FDA | None FDA-2015-N-0101 | 039 Reference 28 - Comparative in vitro activities of topical wound care products against community-associated methicillin-resistant Staphylococcus aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:10:56Z | 0 | 0 | 0900006482cea5a7 | |||
| FDA-2015-N-0101-1400 | FDA | None FDA-2015-N-0101 | 049 Reference 38 - Comparative in vitro efficacy of antimicrobial re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:18:18Z | 0 | 0 | 0900006482cea5b1 | |||
| FDA-2015-N-0101-1367 | FDA | None FDA-2015-N-0101 | 016 Reference 5 - Part 130 New Drugs-Procedures for Classification of Over-the-Counter Drugs re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:51:15Z | 0 | 0 | 0900006482cea906 | |||
| FDA-2015-N-0101-1368 | FDA | None FDA-2015-N-0101 | 017 Reference 6 - Tuuli et al, A randomized trial comparing skin antiseptic agents at cesarean delivery re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:51:57Z | 0 | 0 | 0900006482cea907 | |||
| FDA-2015-N-0101-1370 | FDA | None FDA-2015-N-0101 | 019 Reference 8 - Mangram et al, Guideline for prevention of surgical site infection re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:53:43Z | 0 | 0 | 0900006482cea909 | |||
| FDA-2015-N-0101-1353 | FDA | None FDA-2015-N-0101 | 001 Reference 1 - Transcript of the January 22, 1997, Meeting of the Joint Nonprescription Drugs and Anti-Infective Drugs Advisory Committees re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:39:14Z | 0 | 0 | 0900006482ce9f6e | |||
| FDA-2015-N-0101-1360 | FDA | None FDA-2015-N-0101 | 008 Reference 2 -7 - Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_re_Comment_from_Soap_Detergent_Association_(SDA) re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:45:27Z | 0 | 0 | 0900006482cea4bb | |||
| FDA-2015-N-0101-1387 | FDA | None FDA-2015-N-0101 | 036 Reference 25 - USEPA, Guidelines for Reproductive Toxicity Risk Assessment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:08:53Z | 0 | 0 | 0900006482cea5a4 | |||
| FDA-2015-N-0101-1421 | FDA | None FDA-2015-N-0101 | 072 Reference 61 - Gorden and Mclure, In-vitro comparison of bactericidal activity of povidone iodine and re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:36:19Z | 0 | 0 | 0900006482ceabe1 | |||
| FDA-2015-N-0101-1428 | FDA | None FDA-2015-N-0101 | 079 Reference 68 - Coelho et al, The Use of Machine Learning Methodologies to Analyse Antibiotic and Biocide Susceptibility in Staphylococcus Aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:41:52Z | 0 | 0 | 0900006482ceabe8 | |||
| FDA-2015-N-0101-1392 | FDA | None FDA-2015-N-0101 | 041 Reference 30 - Absence of role for plasmids in resistance to multiple disinfectants in three stains re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:12:26Z | 0 | 0 | 0900006482cea5a9 | |||
| FDA-2015-N-0101-1409 | FDA | None FDA-2015-N-0101 | 060 Reference 49 - Rajamohan et al, Biocide-Tolerant Multidrug-Resistant Acinetobacter Baumannii Clinical Strains Are Associated with re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:25:34Z | 0 | 0 | 0900006482cea5bb | |||
| FDA-2015-N-0101-1415 | FDA | None FDA-2015-N-0101 | 066 Reference 55 - Lanker Klossner et al, Nondevelopment of resistance by bacteria during hospital use of povidone-iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T15:30:41Z | 0 | 0 | 0900006482cea7cc | |||
| FDA-2015-N-0101-1365 | FDA | None FDA-2015-N-0101 | 014 Reference 3 - Transcript of the March 23, 2005, Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:49:43Z | 0 | 0 | 0900006482cea904 | |||
| FDA-2015-N-0101-1366 | FDA | None FDA-2015-N-0101 | 015 Reference 4 - Transcript of the September 3, 2014, Meeting of the Nonprescription Drugs Advisory Committee 2014 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | Supporting & Related Material | Background Material | 2017-12-20T05:00:00Z | 2017 | 12 | 2017-12-20T14:50:24Z | 0 | 0 | 0900006482cea905 |
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