FDA Releases Guidance for Cellular Therapy Sponsors

Nov 09, 2010   

The U.S. Food and Drug Administration (FDA) have recently published its guidance document, entitled “Guidance for the Industry: Cellular Therapy for Cardiac Disease.” Found here, this document finalizes and incorporates various comments from last years draft guidance entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease.”  The newly-released guidance is intended for sponsors who are in the process of developing cellular therapies for cardiac disease. 

This Guidance provides various recommendations regarding the design of pre-clinical and clinical studies.  In addition, the document suggests what information the FDA will consider when an Investigational New Drug (IND) application is submitted.  Although the suggestions in this document are non-binding, compliance with these procedures may facilitate the path to FDA approval.

For more information on FDA guidance documents or cellular therapies, please contact us at contact@fidjlaw.com.