“Shedding” risk reported in 2015 – FDA, HHS issued ‘Guidance’ to “industry” on THE RISK of viral, bacterial “shedding” to “untreated individuals” from those receiving ‘Gene Therapy’ (aka modified mRNA)

Adara Press

https://www.fda.gov/media/89036/download

Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic

Products Guidance for Industry

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research

August 2015

I. INTRODUCTION

The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2with recommendations on how to conduct shedding studies during preclinical and clinical development. For purposes of this guidance, the term “shedding” means release of VBGT oroncolytic products from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.) ; or through the skin (pustules, sores, wounds). Shedding is distinct from biodistribution because the latter describes how a product is spread within the patient’s body…

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