BioInsights - Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Cell & Gene Therapy Insights 2022; 8(6), 721–724

DOI: 10.18609/cgti.2022.107

Published: 10 July 2022
Kathleen Candando, Karl Whitney

 “...this newly released guidance document [Human Gene Therapy Products Incorporating Human Genome Editing] from the FDA is very helpful in delineating some expectations for sponsors.”