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78 rows where docket_id = "FDA-2016-N-0124" and posted_year = 2019 sorted by posted_date descending

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  • 2019 · 78 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-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
FDA-2016-N-0124-0305 FDA None FDA-2016-N-0124 Reference 22 - Sivaji, Y., et al., Disinfectant Induced Changes in the Antibiotic Sensitivity and Phage Typing Pattern in 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     2019-06-05T18:58:41Z   0 0 0900006483b6a610
FDA-2016-N-0124-0284 FDA None FDA-2016-N-0124 Reference 7 - FDA Deferral Letter for Ethyl 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     2019-06-05T18:58:25Z   0 0 0900006483b6a928
FDA-2016-N-0124-0295 FDA None FDA-2016-N-0124 Reference 2 – 5 – Volume_V_5_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     2019-06-05T18:58:33Z   0 0 0900006483b6a4d5
FDA-2016-N-0124-0338 FDA None FDA-2016-N-0124 Reference 44 - Buffet-Bataillon, S., et al., Effect of Higher Minimum Inhibitory Concentrations of Quaternary Ammonium Compounds 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     2019-06-05T18:59:11Z   0 0 0900006483b6a63a
FDA-2016-N-0124-0322 FDA None FDA-2016-N-0124 Reference 8 – Brown, T. L., et al., Can Alcohol-Based Hand-Rub Solutions Cause You to Lose Your Driver’s License Comparative 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     2019-06-05T18:58:56Z   0 0 0900006483b6a92b
FDA-2016-N-0124-0304 FDA None FDA-2016-N-0124 Reference 23 - Young, R., et al., Comparative In Vitro Efficacy of Antimicrobial Shampoos A Pilot Study 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     2019-06-05T18:58:40Z   0 0 0900006483b6a611
FDA-2016-N-0124-0323 FDA None FDA-2016-N-0124 Reference 7 – 2 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     2019-06-05T18:58:57Z   0 0 0900006483b6a92a
FDA-2016-N-0124-0342 FDA None FDA-2016-N-0124 Reference 37 - Kawamura-Sato, K., et al., Correlation Between Reduced Susceptibility to Disinfectants and Multidrug Resistance Among Clinical 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     2019-06-05T19:00:47Z   0 0 0900006483b6a95a
FDA-2016-N-0124-0299 FDA None FDA-2016-N-0124 Reference 2 – 1 – Volume_II_2_of_9_Feedback_Meeting_and_Working_Texts_From_the_Feedback_ Meeting_March_29_1995_Attachment_1_through_6 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     2019-06-05T18:58:36Z   0 0 0900006483b6a4d0
FDA-2016-N-0124-0301 FDA None FDA-2016-N-0124 Reference 1 - Transcript of the January 22, 1997, Joint Meeting of the Nonprescription Drugs and Anti 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 0900006483b6a46c
FDA-2016-N-0124-0308 FDA None FDA-2016-N-0124 Reference 19 - Johnson, S. A., et al., Comparative Susceptibility of Resident and Transient Hand Bacteria to Para-chloro- 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     2019-06-05T18:58:43Z   0 0 0900006483b6a60b
FDA-2016-N-0124-0334 FDA None FDA-2016-N-0124 Reference 48 - Morrissey, I., et al., Evaluation of Epidemiological Cut-Off Values Indicates That Biocide Resistant Subpopulations Are Uncommon 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     2019-06-05T18:59:08Z   0 0 0900006483b6a63e
FDA-2016-N-0124-0339 FDA None FDA-2016-N-0124 Reference 43 - Stickler, D. J., et al., Antiseptic and Antibiotic Resistance in Gram-Negative Bacteria Causing Urinary 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     2019-06-05T19:00:44Z   0 0 0900006483b6a962
FDA-2016-N-0124-0337 FDA None FDA-2016-N-0124 Reference 45 - Shi, G. S., et al., Prevalence of Antiseptic-Resistance Genes in Staphylococci Isolated from 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     2019-06-05T18:59:10Z   0 0 0900006483b6a63b
FDA-2016-N-0124-0340 FDA None FDA-2016-N-0124 Reference 42 - Coelho, J. R., et al., The Use of Machine Learning Methodologies to Analyse Antibiotic and Biocide 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     2019-06-05T19:00:45Z   0 0 0900006483b6a961
FDA-2016-N-0124-0335 FDA None FDA-2016-N-0124 Reference 47 - Prince, H. N., et al., Drug Resistance Studies with Topical Antiseptics 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     2019-06-05T18:59:09Z   0 0 0900006483b6a63d
FDA-2016-N-0124-0330 FDA None FDA-2016-N-0124 Reference 28 - Furi, L., et al., Evaluation of Reduced Susceptibility to Quaternary Ammonium Compound 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     2019-06-05T18:59:04Z   0 0 0900006483b6a627
FDA-2016-N-0124-0317 FDA None FDA-2016-N-0124 Reference 10 – Miller, M. A., et. al., Does the Clinical Use of Ethanol-Based Hand Sanitizer Elevate Blood Alcohol Levels 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     2019-06-05T18:58:51Z   0 0 0900006483b6a92d
FDA-2016-N-0124-0303 FDA None FDA-2016-N-0124 Reference 24 - Block, C., et al., Evaluation of Chlorhexidine and Povidone Iodine Activity 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     2019-06-05T18:58:39Z   0 0 0900006483b6a612
FDA-2016-N-0124-0326 FDA None FDA-2016-N-0124 Reference 32 - Shamsudin, M. N., et al., High Prevalence of qacAB Carriage Among Clinical Isolates of Meticillin-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     2019-06-05T18:59:00Z   0 0 0900006483b6a62b
FDA-2016-N-0124-0328 FDA None FDA-2016-N-0124 Reference 30 - Ghasemzadeh-Moghaddam, H., et al., Methicillin-Susceptible and-Resistant Staphylococcus aureus With High-Level 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     2019-06-05T18:59:02Z   0 0 0900006483b6a629
FDA-2016-N-0124-0336 FDA None FDA-2016-N-0124 Reference 46 - Lambert, R. J., Comparative Analysis of Antibiotic and Antimicrobial Biocide Susceptibility Data 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     2019-06-05T18:59:10Z   0 0 0900006483b6a63c
FDA-2016-N-0124-0331 FDA None FDA-2016-N-0124 Reference 27 - Liu, Q., et al., Sensitivities to Biocides and Distribution of Biocide Resistance Genes in Quaternary Ammonium Compound Tolerant 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     2019-06-05T18:59:05Z   0 0 0900006483b6a626
FDA-2016-N-0124-0306 FDA None FDA-2016-N-0124 Reference 21 - Sivaji, Y. and A. Mandal, Antibiotic Resistance and Serotypic Variations in Escherichia coli Induced by 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 0900006483b6a60f
FDA-2016-N-0124-0285 FDA None FDA-2016-N-0124 Reference 6 - Transcript of the September 3, 2014, Meeting of the Nonprescription Drugs Advisory Committee 2014 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     2019-06-05T18:58:26Z   0 0 0900006483b6a927
FDA-2016-N-0124-0316 FDA None FDA-2016-N-0124 Reference 11 – Food and Drug Administration, Guidance for Industry. Maximal Usage Trials for Topical Active Ingredients Being Considered 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     2019-06-05T18:58:50Z   0 0 0900006483b6a937
FDA-2016-N-0124-0296 FDA None FDA-2016-N-0124 Reference 2 – 4 – Volume_IV_4_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     2019-06-05T18:58:34Z   0 0 0900006483b6a4d4
FDA-2016-N-0124-0314 FDA None FDA-2016-N-0124 Reference 13 - Bearden, D. T., et al., Comparative In Vitro Activities of Topical Wound Care Products Against 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     2019-06-05T18:58:48Z   0 0 0900006483b6a939
FDA-2016-N-0124-0283 FDA None FDA-2016-N-0124 Briefing Document from Lewis and Harrison on behalf of Lonza Inc. and Henkel Consumer Goods, Inc. Other Brief 2019-05-31T04:00:00Z 2019 5 2019-05-31T04:00:00Z   2019-05-31T20:36:58Z   0 0 0900006483cddf54
FDA-2016-N-0124-0281 FDA None FDA-2016-N-0124 Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Rule Final Rule 2019-04-12T04:00:00Z 2019 4 2019-04-12T04:00:00Z   2019-04-12T13:14:40Z 2019-06791 0 0 0900006483b89f68
FDA-2016-N-0124-0279 FDA None FDA-2016-N-0124 Letter from FDA CDER to Bayer Corporation Other Letter(s) 2019-04-11T04:00:00Z 2019 4 2019-04-11T04:00:00Z   2019-04-11T16:48:48Z   0 0 0900006483b85971
FDA-2016-N-0124-0278 FDA None FDA-2016-N-0124 Letter from FDA CDER to Ciba Specialty Chemicals Corporation Other Letter(s) 2019-04-11T04:00:00Z 2019 4 2019-04-11T04:00:00Z   2019-04-11T16:46:32Z   0 0 0900006483b856f5
FDA-2016-N-0124-0280 FDA None FDA-2016-N-0124 Letter from FDA CDER to Ciba Specialty Chemicals Corporation Other Letter(s) 2019-04-11T04:00:00Z 2019 4 2019-04-11T04:00:00Z   2019-04-11T16:51:14Z   0 0 0900006483b85974
FDA-2016-N-0124-0277 FDA None FDA-2016-N-0124 Request for a Type C Meeting from Lewis and Harrison on behalf of Lorenz Inc., and Henkel Corporation Other Request 2019-04-09T04:00:00Z 2019 4 2019-04-09T04:00:00Z   2019-04-09T19:01:15Z   0 0 0900006483b7a9d3
FDA-2016-N-0124-0276 FDA None FDA-2016-N-0124 Request for a Deferral from Keller and Heckman LLP on behalf of CleanWell LLC Other Request 2019-03-26T04:00:00Z 2019 3 2019-03-26T04:00:00Z   2019-03-26T21:16:11Z   0 0 0900006483b319e2
FDA-2016-N-0124-0275 FDA None FDA-2016-N-0124 Report from American Cleaning Institute (ACI) Other Report 2019-03-13T04:00:00Z 2019 3 2019-03-13T04:00:00Z   2019-03-13T20:22:54Z   0 0 0900006483ad8541

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