OTC Monograph Meeting Calendar
For sunscreen-related meetings, visit the sunscreen meeting page.
2016
March
- March 20, 2015: Meeting to obtain clarification on the human pharmacokinetic maximal use trial (MusT) as outlined in the October 15, 2015 FDA General Advice letter and the Memorandum of Meeting Minutes from the meeting held between Lonza America Inc., and the FDA on May 6, 2015; and 2) discussing the process of requesting a time extension for completion of the MUsT and other safety data required for support of a Generally Recognized as Safe (GRAS) listing for benzethonium chloride and benzalkonium chloride.
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2015
October
- October 20, 2015: A meeting to discuss the data gaps identified for isopropyl alcohol for use in patient preoperative skin preparations, healthcare personnel hand rubs, and surgical hand rubs in the May 1, 2015 proposed rule “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record”.
July
- July 30, 2015: A meeting to discuss the protocols submitted to FDA Docket No. FDA-2015-N-0101 “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record” regarding Physiologically-Based Pharmacokinetic (PBPK) Modeling, formulation variances and efficacy for Ethyl Alcohol.
May
- May 11, 2015: A meeting to discuss the proposed order issued to L’Oréal USA on February 25, 2015 pertaining to the safety and efficacy submission on Ecamsule as authorized under the Time and Extent Application procedures in 21 CFR 330.14.
- May 6, 2015: A meeting to discuss protocols submitted to FDA Docket No. FDA-1975-N-0012 regarding maximal use test studies and screening studies for potential endocrine effects (benzethonium chloride and benzalkonium chloride).
April
- April 24, 2015: Discuss data submitted to the Agency on chloroxylenol, and to discuss the remaining safety data gaps and how they may be filled.
March
- March 18, 2015: Discuss the proposed order issued to L’Oréal USA on August 29, 2014 pertaining to the safety and efficacy submission on drometrizole trisiloxane in sunscreens as authorized under the Time and Extent Application procedures in 21 CFR 330.14.
- March 19, 2015: Meeting to discuss the proposed orders pertaining to FDA’s review of the safety and efficacy data to support the GRASE status of the sunscreen filters Octyl Triazone and Bemotrizinol.
- March 20, 2015: Meeting concerning Safety Data; Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Docket Number: FDA-1975-N-0012.
- Letter Granting Meeting Request
- Meeting Minutes
- Written Advice
- Deferral letter from FDA CDER to American Cleaning Institute and Henkel North America regarding Review of Chloroxylenol
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- Deferral letter from FDA CDER to Lonza America, Inc., American Cleaning Institute and Henkel North America regarding Review of Benzalkonium Chloride
- Deferral letter from FDA CDER to Lonza America, Inc., American Cleaning Institute and Henkel North America regarding Review of Benzethonium Chloride
- Advice Letter from FDA CDER to American Cleaning Institute
- Advice Letter from FDA CDER to American Cleaning Institute
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March 20, 2015: Meeting to discuss the proposed order pertaining to FDA’s review of the safety and efficacy data to support the GRASE status of the sunscreen filter Bisoctrizole