Day: February 13, 2025

A recent Warning Letter for conducting clinical trials with a supplement without FDA approval highlights the fine line that separates trials that need the FDA’s pre-approval to initiate and those that don’t. The FDA inspectors dinged a company in California for conducting multiple clinical trials with their probiotics because of certain endpoints selected for those … Read more

Conducting clinical trials for heart-related diseases in the U.S. is difficult, even though these diseases affect many people. To gather enough participants, trials often need large networks of locations both in the U.S. and internationally. If a study does not enroll enough people, it can face delays, waste resources, and take longer to complete. Because … Read more