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Guidance Documents/Guidance-Document/Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations

Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

May 10, 2019

April 11, 2024

Center for Drug Evaluation and Research

aba27acd-a192-453b-9d48-dde390d1e56f

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