US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies
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...
Julie Tierney will become CBER’s deputy director for strategy, policy and legislation, a newly created position.
CBER’s director says manufacturing and regulatory issues need to be resolved to ensure the gene therapy sector thrives.
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.