# Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-use-of-the-plausible-mechanism-framework-to-develop-individualized-therapies-that-target-specific-genetic-conditions-with-known-biological-cause/2a636aa3-3bb2-4828-83f2-b5eb7244721b > FDA guidance document: Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause. Issue date: February 23, 2026. Get complete insights and analysis. --- ## Details - Title: Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause - Communication Type: Guidance Document - Product Type: biologics - Office Name: Center for Biologics Evaluation and Research - Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d - Issue Date: 2026-02-23 - Last Changed: 2026-02-23 - Docket Number: FDA-2026-D-1256 ## Related Documents - [Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing](https://www.globalkeysolutions.net/guidances/guidance-document/safety-assessment-of-genome-editing-in-human-gene-therapy-products-using-next-generation-sequencing/8bd86906-9b70-4e40-ae4a-dde0c1ea99ca) - [Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/postapproval-methods-to-capture-safety-and-efficacy-data-for-cell-and-gene-therapy-products-draft-guidance-for-industry/d076649d-1260-49fb-bc96-30f59be10ea0) - [Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/expedited-programs-for-regenerative-medicine-therapies-for-serious-conditions-draft-guidance-for-industry/4c570099-1582-4019-8f81-d0260a2e984c)