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363 rows where agency_id = "FDA" and docket_id = "FDA-2016-N-0124" sorted by posted_date descending

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  • FDA · 363 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0124-0413 FDA None FDA-2016-N-0124 FINAL Third Extension Deferral Letter Other Letter(s) 2022-05-31T04:00:00Z 2022 5 2022-05-31T04:00:00Z   2022-05-31T14:54:57Z   0 0 0900006483e57838
FDA-2016-N-0124-0410 FDA None FDA-2016-N-0124 Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Notice Notice of Availability 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2020-12-31T14:14:51Z 2020-28929 0 0 09000064849d654d
FDA-2016-N-0124-0411 FDA None FDA-2016-N-0124 Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Other Guidance 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2024-11-12T23:26:51Z   1 0 09000064849d6159
FDA-2016-N-0124-0409 FDA None FDA-2016-N-0124 The American CIeaning Institute Progress Report Other Report 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T16:13:10Z   0 0 0900006484986dd5
FDA-2016-N-0124-0408 FDA None FDA-2016-N-0124 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   2020-11-23T13:08:25Z   0 0 0900006484970496
FDA-2016-N-0124-0407 FDA None FDA-2016-N-0124 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   2020-11-20T14:38:40Z   0 0 090000648496ca62
FDA-2016-N-0124-0406 FDA None FDA-2016-N-0124 ACI Advice November 18 2020 Other Letter(s) 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z   2020-11-20T14:34:16Z   0 0 090000648496ca5c
FDA-2016-N-0124-0405 FDA None FDA-2016-N-0124 ACI BZT Monograph Meeting Minutes Written Responses Supporting & Related Material Meeting Materials 2020-10-06T04:00:00Z 2020 10     2020-10-06T14:59:41Z   0 0 09000064848de180
FDA-2016-N-0124-0404 FDA None FDA-2016-N-0124 Meeting Minutes for Lonza & Henkel’s benzalkonium chloride consumer antiseptic hand wash July 30 2020 Other Minutes 2020-08-26T04:00:00Z 2020 8 2020-08-26T04:00:00Z   2020-08-26T13:56:29Z   0 0 09000064848202dd
FDA-2016-N-0124-0395 FDA None FDA-2016-N-0124 Lonza Inc. Data Listing 16.2.7.1: Adverse Events Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:09:31Z   0 0 0900006484719149
FDA-2016-N-0124-0389 FDA None FDA-2016-N-0124 Lonza, Inc. and Henkel Corporation, Inc. Signatures of Authors, Principal Investigator, and Sponsor's Medical Officer re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:51:09Z   0 0 0900006484719143
FDA-2016-N-0124-0403 FDA None FDA-2016-N-0124 Lonza Inc. Table 14.1.1: Summary of Subject Enrollment and Disposition re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:27:08Z   0 0 0900006484719220
FDA-2016-N-0124-0393 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.5.1: Plasma Concentration (ng/L) - C12 homologs Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:04:49Z   0 0 0900006484719147
FDA-2016-N-0124-0386 FDA None FDA-2016-N-0124 Henkel Corporation, Inc. Lonza Inc. Case Report Form Booklet Final Version # 1.0 November 04, 2019 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:42:31Z   0 0 0900006484719140
FDA-2016-N-0124-0390 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.1 Subject Disposition and Population Inclusion All Enrolled Subjects (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:59:15Z   0 0 0900006484719144
FDA-2016-N-0124-0399 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.11: Childbearing Potential and Urine Pregnancy Test Results All Female Subjects (N= 20) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:17:26Z   0 0 090000648471921c
FDA-2016-N-0124-0402 FDA None FDA-2016-N-0124 Lonza Inc. Figure 14.2.2.1: Individual Subject Plasma Levels, Linear for C12 and C14 homologs, PK Population Subject Number: 0001 at Day 1 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:25:07Z   0 0 090000648471921f
FDA-2016-N-0124-0400 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.12: Comments Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:19:32Z   0 0 090000648471921d
FDA-2016-N-0124-0387 FDA None FDA-2016-N-0124 Lonza Inc. INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:45:15Z   0 0 0900006484719141
FDA-2016-N-0124-0385 FDA None FDA-2016-N-0124 Henkel Corporation, Inc. Lonza Inc. A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:42:03Z   0 0 0900006484718cdb
FDA-2016-N-0124-0391 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.2 Protocol Deviations Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:01:01Z   0 0 0900006484719145
FDA-2016-N-0124-0396 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.8: Vital Signs Test Results Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:11:56Z   0 0 0900006484719219
FDA-2016-N-0124-0398 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.10.1: Laboratory Test Results, Chemistry, Part 1 Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:15:35Z   0 0 090000648471921b
FDA-2016-N-0124-0397 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.9: Physical Examination Results - Abnormal Findings Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:13:50Z   0 0 090000648471921a
FDA-2016-N-0124-0401 FDA None FDA-2016-N-0124 Henkel Corporation, Inc. Lonza Inc.A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:23:13Z   0 0 090000648471921e
FDA-2016-N-0124-0394 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.6.1: Hand Wash and Packaging Weights Details Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:07:10Z   0 0 0900006484719148
FDA-2016-N-0124-0384 FDA None FDA-2016-N-0124 Lonza Inc. A Pivotal Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin in Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:42:18Z   0 0 0900006484718cd5
FDA-2016-N-0124-0392 FDA None FDA-2016-N-0124 Lonza Inc. Listing 16.2.4.1: Demographics and Baseline Characteristics Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:02:58Z   0 0 0900006484719146
FDA-2016-N-0124-0388 FDA None FDA-2016-N-0124 Curriculum Vitaes re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:48:34Z   0 0 0900006484719142
FDA-2016-N-0124-0370 FDA None FDA-2016-N-0124 16-5-4-representative-chromatograms Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:34Z   0 0 090000648470d5dd
FDA-2016-N-0124-0383 FDA None FDA-2016-N-0124 16-6-ba-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:37:09Z   0 0 090000648470d617
FDA-2016-N-0124-0375 FDA None FDA-2016-N-0124 16-5-2-coas-of-reference-standards Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:30:08Z   0 0 090000648470d52b
FDA-2016-N-0124-0361 FDA None FDA-2016-N-0124 Appendix 3_lonza_pmut_052019_csr Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:15:28Z   0 0 090000648470bb28
FDA-2016-N-0124-0367 FDA None FDA-2016-N-0124 16-5-7-incurred-samples-reanalysis-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:05Z   0 0 090000648470d5d1
FDA-2016-N-0124-0376 FDA None FDA-2016-N-0124 16-5-3-representative-chromatograms Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:31:05Z   0 0 090000648470d52c
FDA-2016-N-0124-0369 FDA None FDA-2016-N-0124 16-5-5-result-tables-of-all-runs Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:24Z   0 0 090000648470d5d5
FDA-2016-N-0124-0359 FDA None FDA-2016-N-0124 Appendix 1_Lonza FINAL July 3_2019 Prelim Meeting Preliminary Commt for July 2019 MTG Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:15:13Z   0 0 090000648470bb2a
FDA-2016-N-0124-0378 FDA None FDA-2016-N-0124 16-5-5-Criteria-for-sample-reanalysis-and-reporting-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:32:46Z   0 0 090000648470d2b0
FDA-2016-N-0124-0362 FDA None FDA-2016-N-0124 16-6-ba-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:06Z   0 0 090000648470d1e6
FDA-2016-N-0124-0379 FDA None FDA-2016-N-0124 16-5-6-incurred-samples-reanalysis-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:33:33Z   0 0 090000648470d2b6
FDA-2016-N-0124-0371 FDA None FDA-2016-N-0124 16-5-3-multianalyte-reanalysis-batches-data Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:43Z   0 0 090000648470d5df
FDA-2016-N-0124-0372 FDA None FDA-2016-N-0124 16-5-2-coas-of-reference-standards Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:54Z   0 0 090000648470d5e1
FDA-2016-N-0124-0364 FDA None FDA-2016-N-0124 16-6-2-ba-2nd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:26Z   0 0 090000648470d1ea
FDA-2016-N-0124-0374 FDA None FDA-2016-N-0124 16-5-1-preparation-acceptance-criteria-for-cc-qc-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:29:21Z   0 0 090000648470d52a
FDA-2016-N-0124-0357 FDA None FDA-2016-N-0124 Briefing Document BAC June 2020_Final Other Memo 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T17:12:57Z   0 0 090000648470c918
FDA-2016-N-0124-0368 FDA None FDA-2016-N-0124 16-5-6-Criteria-for-sample-reanalysis-and-reporting-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:15Z   0 0 090000648470d5d3
FDA-2016-N-0124-0381 FDA None FDA-2016-N-0124 16-6-1-ba-1st-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:35:16Z   0 0 090000648470d2b8
FDA-2016-N-0124-0373 FDA None FDA-2016-N-0124 16-5-1-preparation-acceptance-criteria-for-cc-qc-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:23:04Z   0 0 090000648470d5e3
FDA-2016-N-0124-0358 FDA None FDA-2016-N-0124 Lonza Study No_TKL MC000520 CSP Final v1.0 19June2020 - signed Other Studies 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T17:13:28Z   0 0 090000648470c91a
FDA-2016-N-0124-0360 FDA None FDA-2016-N-0124 Appendix 2_BAC IVDP Foaming Liquid Handwashes 06.2020 CRL FINAL Report Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:15:20Z   0 0 090000648470bb29
FDA-2016-N-0124-0377 FDA None FDA-2016-N-0124 16-5-4-result-tables-of-all-runs Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:32:00Z   0 0 090000648470d52d
FDA-2016-N-0124-0365 FDA None FDA-2016-N-0124 16-6-1-ba-1st-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:36Z   0 0 090000648470d5cd
FDA-2016-N-0124-0380 FDA None FDA-2016-N-0124 16-5-bioanalyt-pmut-052019 Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:34:23Z   0 0 090000648470d2b7
FDA-2016-N-0124-0363 FDA None FDA-2016-N-0124 16-6-3-ba-3rd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:15Z   0 0 090000648470d1e8
FDA-2016-N-0124-0382 FDA None FDA-2016-N-0124 16-6-2-ba-2nd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:36:15Z   0 0 090000648470d2b9
FDA-2016-N-0124-0366 FDA None FDA-2016-N-0124 16-5-bioanalyt-pmut-052019 Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:55Z   0 0 090000648470d5cf
FDA-2016-N-0124-0356 FDA None FDA-2016-N-0124 MONOGRAPH Meeting Granted Letter Lonza and Henkel 2020 Benzalkonium Hand Soaps Other Request 2020-06-24T04:00:00Z 2020 6 2020-06-24T04:00:00Z   2020-06-24T13:02:40Z   0 0 0900006484704aad
FDA-2016-N-0124-0354 FDA None FDA-2016-N-0124 Request for Type C Meeting from Lewis and Harrison to FDA CDER/DNDP/ ODE IV Other Request 2020-03-13T04:00:00Z 2020 3 2020-03-13T04:00:00Z   2020-03-13T20:20:10Z   0 0 0900006484443e02
FDA-2016-N-0124-0353 FDA None FDA-2016-N-0124 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   2019-10-17T15:39:32Z   0 0 09000064840b4539
FDA-2016-N-0124-0352 FDA None FDA-2016-N-0124 Lonza FINAL July 3_2019 Prelim Meeting Preliminary Comment for July 2019 MTG (002) Other Minutes 2019-09-19T04:00:00Z 2019 9 2019-09-19T04:00:00Z   2019-09-19T18:24:21Z   0 0 0900006483f9ee0c
FDA-2016-N-0124-0351 FDA None FDA-2016-N-0124 Letter from FDA CDER to American Cleaning Institute Other Letter(s) 2019-08-09T04:00:00Z 2019 8 2019-08-09T04:00:00Z   2019-08-09T12:57:05Z   0 0 0900006483e1e09f
FDA-2016-N-0124-0350 FDA None FDA-2016-N-0124 Letter from FDA CDER to American Cleaning Institute Other Letter(s) 2019-07-15T04:00:00Z 2019 7 2019-07-15T04:00:00Z   2019-07-15T18:46:13Z   0 0 0900006483d91e24
FDA-2016-N-0124-0349 FDA None FDA-2016-N-0124 LONZA Meeting Request for July 9 Cancelled Other Letter(s) 2019-07-09T04:00:00Z 2019 7 2019-07-09T04:00:00Z   2019-07-09T15:55:34Z   0 0 0900006483d6f60a
FDA-2016-N-0124-0348 FDA None FDA-2016-N-0124 Letter from FDA CDER to Lewis & Harrison Other Letter(s) 2019-06-12T04:00:00Z 2019 6 2019-06-12T04:00:00Z   2019-09-19T16:52:24Z   0 0 0900006483d09577
FDA-2016-N-0124-0307 FDA None FDA-2016-N-0124 Reference 20 - Kolawole, D. O., Resistance Mechanisms of Mucoid-Grown Staphylococcus aureus to the Antibacterial Action of Some Disinfectants re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:42Z   0 0 0900006483b6a60c
FDA-2016-N-0124-0318 FDA None FDA-2016-N-0124 Reference 40 - Lanker Klossner, B., et al., Nondevelopment of Resistance by Bacteria During Hospital Use of Povidone-Iodine re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:52Z   0 0 0900006483b6a95d
FDA-2016-N-0124-0294 FDA None FDA-2016-N-0124 Reference 2 – 6 – Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:32Z   0 0 0900006483b6a5f0
FDA-2016-N-0124-0325 FDA None FDA-2016-N-0124 Reference 33 - Weber, D. J. and W. A. Rutala, Use of Germicides in the Home and the Healthcare re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:59Z   0 0 0900006483b6a62c
FDA-2016-N-0124-0333 FDA None FDA-2016-N-0124 Reference 49 - Copitch, J. L., et al., Prevalence of Decreased Susceptibility to Triclosan in Salmonella re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:59:07Z   0 0 0900006483b6a63f
FDA-2016-N-0124-0344 FDA None FDA-2016-N-0124 Reference 35 - Akinkunmi, E. O. and A. Lamikanra, Susceptibility of Community Associated Methicillin Resistant re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T19:00:48Z   0 0 0900006483b6a62e
FDA-2016-N-0124-0297 FDA None FDA-2016-N-0124 Reference 2 – 3 – Volume_IV_3_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:34Z   0 0 0900006483b6a4d3
FDA-2016-N-0124-0343 FDA None FDA-2016-N-0124 Reference 36 - Kawamura-Sato, K., et al., Reduction of Disinfectant Bactericidal Activities in Clinically Isolated Acinetobacter species in the re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T19:00:48Z   0 0 0900006483b6a959
FDA-2016-N-0124-0341 FDA None FDA-2016-N-0124 Reference 41 - Oggioni, M. R., et al., Significant Differences Characterize the Correlation Coefficients Between Biocide and Antibiotic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T19:00:46Z   0 0 0900006483b6a960
FDA-2016-N-0124-0312 FDA None FDA-2016-N-0124 Reference 15 - Nagai, I. and H. Ogase, Absence of Role for Plasmids in Resistance to Multiple Disinfectants in Three re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:46Z   0 0 0900006483b6a93b
FDA-2016-N-0124-0320 FDA None FDA-2016-N-0124 Reference 38 - Khor, S. Y. and M. Jegathesan, In-Use testing of Disinfectants in Malaysian Government Hospitals re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:54Z   0 0 0900006483b6a95b
FDA-2016-N-0124-0302 FDA None FDA-2016-N-0124 Reference.List.Consumer.Rub.Final.Rule.2019 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:38Z   0 0 0900006483b6a46b
FDA-2016-N-0124-0300 FDA None FDA-2016-N-0124 Reference 2 - Comment submitted in Docket No. FDA-1975-N-0012-0081. Volume_I_1_of_9_Soap_ and_Detergent_ re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:37Z   0 0 0900006483b6a4cf
FDA-2016-N-0124-0332 FDA None FDA-2016-N-0124 Reference 50 - FDA Deferral Letter for Benzalkonium Chloride in Consumer Rub Antiseptics on October 31, 2017 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:59:06Z   0 0 0900006483b6a640
FDA-2016-N-0124-0310 FDA None FDA-2016-N-0124 Reference 17 - Sakagami, Y. and K. Kajimura, Bactericidal Activities of Disinfectants against Vancomycin re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:45Z   0 0 0900006483b6a93d
FDA-2016-N-0124-0345 FDA None FDA-2016-N-0124 Reference 26 - Lacey, R. W., et al., Antiseptic Resistance in Methicillin-Resistant Staphylococcus aureus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T19:00:49Z   0 0 0900006483b6a625
FDA-2016-N-0124-0347 FDA None FDA-2016-N-0124 Reference 7 – 1 FDA Deferral Letter for Isopropyl Alcohol in Consumer Rub Antiseptics on October 31, 2017 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T19:00:51Z   0 0 0900006483b6a929
FDA-2016-N-0124-0309 FDA None FDA-2016-N-0124 Reference 18 - Haley, C. E., et al., Bactericidal Activity of Antiseptics Against Methicillin-Resistant Staphylococcus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:44Z   0 0 0900006483b6a60a
FDA-2016-N-0124-0346 FDA None FDA-2016-N-0124 Reference 25 - Kunisada, T., et al., Investigation on the Efficacy of Povidone-Iodine Against Antiseptic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T19:00:50Z   0 0 0900006483b6a613
FDA-2016-N-0124-0287 FDA None FDA-2016-N-0124 Reference 4 - Transcript of the October 20, 2005, Meeting of the Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:28Z   0 0 0900006483b6a925
FDA-2016-N-0124-0321 FDA None FDA-2016-N-0124 Reference 9 – Kramer, A., et. al., Quantity of Ethanol Absorption After Excessive Hand Disinfection Using Three Commercially re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:55Z   0 0 0900006483b6a92c
FDA-2016-N-0124-0313 FDA None FDA-2016-N-0124 Reference 14 - Czerwinski, S. E., et al., Novel Water-Based Antiseptic Lotion Demonstrates Rapid, Broad- Spectrum Kill Compared re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:47Z   0 0 0900006483b6a93a
FDA-2016-N-0124-0292 FDA None FDA-2016-N-0124 Reference 2 – 8 – Volume_VII_7_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:31Z   0 0 0900006483b6a5f5
FDA-2016-N-0124-0289 FDA None FDA-2016-N-0124 Reference 2 – 11 – Volume_IX_9_of_9_Publsihed_Cited_ References_Part_2_of_2_re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:29Z   0 0 0900006483b6a5f8
FDA-2016-N-0124-0286 FDA None FDA-2016-N-0124 Reference 5 - Summary Minutes of the November 14, 2008, Feedback Meeting with Personal re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:27Z   0 0 0900006483b6a926
FDA-2016-N-0124-0319 FDA None FDA-2016-N-0124 Reference 39 - Rikimaru, T., et al., Bactericidal Activities of Commonly Used Antiseptics Against Multidrug-Resistant Mycobacterium re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:53Z   0 0 0900006483b6a95c
FDA-2016-N-0124-0327 FDA None FDA-2016-N-0124 Reference 31 - Noguchi, N., et al., Susceptibilities to Antiseptic Agents and Distribution of Antiseptic- Resistance Genes qacAB and smr re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:59:01Z   0 0 0900006483b6a62a
FDA-2016-N-0124-0324 FDA None FDA-2016-N-0124 Reference 34 - Rajamohan, G., et al., Biocide-Tolerant Multidrug-Resistant Acinetobacter baumannii Clinical Strains Are Associated with re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:58Z   0 0 0900006483b6a62d
FDA-2016-N-0124-0329 FDA None FDA-2016-N-0124 Reference 29 - Babaei, M et al Extremely re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:59:03Z   0 0 0900006483b6a628
FDA-2016-N-0124-0311 FDA None FDA-2016-N-0124 Reference 16 - Geraldo, I. M., et al., Rapid Antibacterial Activity of 2 Novel Hand Soaps re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:46Z   0 0 0900006483b6a93c
FDA-2016-N-0124-0315 FDA None FDA-2016-N-0124 Reference 12 - Food and Drug Administration, Guidance for Industry. M3(R2) Nonclinical Safety Studies for the Conduct of re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:49Z   0 0 0900006483b6a938
FDA-2016-N-0124-0293 FDA None FDA-2016-N-0124 Reference 2 – 7 – Volume_VI_6_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:32Z   0 0 0900006483b6a5f4
FDA-2016-N-0124-0290 FDA None FDA-2016-N-0124 Reference 2 – 10 – Volume_IX_9_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:29Z   0 0 0900006483b6a5f7
FDA-2016-N-0124-0298 FDA None FDA-2016-N-0124 Reference 2 – 2 – Volume_III_3_of_9_Reference_List_re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:35Z   0 0 0900006483b6a4d1
FDA-2016-N-0124-0291 FDA None FDA-2016-N-0124 Reference 2 – 9 – Volume_VIII_8_of_9_References_Continuation_ re_ Comment_Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:30Z   0 0 0900006483b6a5f6
FDA-2016-N-0124-0288 FDA None FDA-2016-N-0124 Reference 3 - Transcript of the March 23, 2005, Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2019-06-05T04:00:00Z 2019 6     2019-06-05T18:58:28Z   0 0 0900006483b6a5f9

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