Day: September 19, 2024

Clinical trials have become increasingly globalized over the last three decades with sponsors routinely conducting multinational clinical trials to evaluate new drugs. A new guidance document from the FDA seems to indicate that the FDA would like to buck that trend. The guidance document lists several previous requirements with a new tone that seems to … Read more

Remote or decentralized clinical trials can make the lives of all stakeholders simpler while yielding high-quality data. Most clinical trials these days involve hybrid systems where parts of the traditional clinical trial activities are conducted remotely. The sponsors must understand the FDA’s expectations from such trials. A new FDA Guidance Document released this week helps … Read more