# Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations - FDA Guidance Document Source: https://www.keypedia.com/guidances/guidance-document/maximal-usage-trials-for-topically-applied-active-ingredients-being-considered-for-inclusion-in-an-over-the-counter-monograph-study-elements-and-considerations/aba27acd-a192-453b-9d48-dde390d1e56f > FDA guidance document: Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations. Issue date: May 10, 2019. Get complete insights and analysis. --- ## Details - Title: Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2019-05-10 - Last Changed: 2024-04-11 - Docket Number: FDA-2018-D-1456 ## Related Documents - [Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease](https://www.keypedia.com/guidances/guidance-document/developing-targeted-therapies-in-low-frequency-molecular-subsets-of-a-disease/becd1349-aa73-4de3-83cd-a43abfb0f98c) - [Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/considerations-in-demonstrating-interchangeability-with-a-reference-product-guidance-for-industry/3c6c8653-5a0c-4cb1-b776-530e73843765) - [Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials](https://www.keypedia.com/guidances/guidance-document/considerations-for-the-inclusion-of-adolescent-patients-in-adult-oncology-clinical-trials/d9024369-3d11-4161-a606-70ab031e8871)