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  1. Center for Drug Evaluation and Research | CDER

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.

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

April

March

 

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