BioCentury
ARTICLE | Politics & Policy

FDA finalizing policies to promote gene therapies

May 22, 2018 4:44 PM UTC

FDA will soon release a framework to facilitate manufacturing of gene therapies, and will lay out development strategies for gene therapies to treat specific diseases, FDA Commissioner Scott Gottlieb said Tuesday.

In remarks prepared for delivery at a meeting of the Alliance for Regenerative Medicine, Gottlieb highlighted the need to overcome manufacturing challenges, as well as the potential role of accelerated approval to speed therapies to patients while ensuring that long-term efficacy and safety questions are answered...