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

 

This “Guidance for Industry” report issued in August of 2015 by the U.S. Department of Health and Human Services, the Food and Drug Administration, and the Center for Biologics Evaluation and Research shows quite clearly that the U.S. Federal Government knew that “shedding” of these Biologics Blood Vaccines would occur.

 

Design and Analysis of Shedding Studies
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