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1,443 rows where docket_id = "FDA-2015-N-0101" sorted by posted_date descending

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  • FDA 1,443
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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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CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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