Day: October 17, 2024

Twenty years ago, the FDA halted all gene therapy clinical trials based on reports from France of cancers in children who received gene therapy. When last week, it was reported that deadly cancers emerged within 2 years in seven out of 67 children who received an FDA-approved gene therapy, the Agency took a wait and … Read more

Most discussions about the lack of diversity in clinical trials are focused on studies for drugs and biologics, not much is discussed publicly about the diversity of trial participants in medical device clinical trials. This week the FDA started publishing the “Device Trial Participation Snapshots” which shows important demographic trends for medical device clinical trials. … Read more