New Guidances: Consumer Antiseptic Wash/ M4E(R2) CTD/ IRB Waiver or Alteration of Informed Consent

New Guidance Documents

1. Consumer Antiseptic Wash Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide

This guidance is intended to help small businesses better understand and comply with the final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE), and thus, are ineligible for inclusion in the OTC topical antiseptic monograph. On September 6, 2016, FDA published a final rule that finalizes the nonmonograph status of 19 active ingredients, including triclosan and triclocarban, which are intended for use in OTC consumer antiseptic wash product.. Three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol — were deferred from the final rule to allow more time for sponsors who proposed to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients. These deferrals are for one year, subject to renewal if adequate progress is made in filling the data gaps. 

2. M4E(R2): The Common Technical Document—Efficacy; International Council for Harmonisation; Guidance for Industry

This revised guidance standardizes the presentation of benefit-risk information in regulatory submissions, providing greater specificity on the format and structure of benefit-risk information. This revision is intended to facilitate communication among regulators and industry.

3. Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards

This guidance informs sponsors, investigators, IRBs, and other interested parties that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, it explains that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance.