US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies
Executive Summary
OTP Director Nicole Verdun acknowledged the agency may need help to determine how to ensure 15 years of patient follow-up is completed despite physician retirements, company closures and other issues that could impact the post-market commitments for gene therapies.
You may also be interested in...
US FDA Chief Of Staff Returning To CBER For Deputy Director Role
Julie Tierney will become CBER’s deputy director for strategy, policy and legislation, a newly created position.
‘Pull Every Lever’: FDA’s Marks Worries Gene Therapies Could Falter Without Help To Lower Cost
CBER’s director says manufacturing and regulatory issues need to be resolved to ensure the gene therapy sector thrives.
US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered
Some worries about heritable genetic modifications are subsiding and Center for Biologics Evaluation and Research Director Peter Marks said sponsors should consider the US for regulatory advice and clinical trials in the space.