FDA Guidance for Industry: Consumer Antiseptic Wash Final Rule - Questions and Answers

Titel:
FDA Guidance for Industry: Consumer Antiseptic Wash Final Rule - Questions and Answers
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM568513.pdf

Inhalt:
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.

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