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57 rows where docket_id = "FDA-2016-N-0124" and posted_year = 2020 sorted by posted_date descending
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document_type 3
- Other 32
- Supporting & Related Material 24
- Notice 1
posted_year 1
- 2020 · 57 ✖
agency_id 1
- FDA 57
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-0124-0410 | 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 |
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