# Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry - FDA Guidance Document Source: 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 > FDA guidance document: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry. Issue date: September 24, 2025. Get complete insights and analysis. --- ## Details - Title: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry - Communication Type: Guidance Document - Product Type: biologics - Office Name: Center for Biologics Evaluation and Research - Office URL: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: 2025-09-24 - Last Changed: 2025-09-24 - Docket Number: FDA-2017-D-6159 ## 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) - [Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause](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) - [Potency Assurance for Cellular and Gene Therapy Products](https://www.globalkeysolutions.net/guidances/guidance-document/potency-assurance-for-cellular-and-gene-therapy-products/2a9b0d81-9dd5-43cf-994c-ac0df102c216)