Newsletter - September 19, 2024
Has the FDA Stopped Accepting Multinational Clinical Trials for Oncology Drugs?
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...Read More
FDA’s New Guidance on Decentralized Clinical Trials
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. Read More
Has the FDA Stopped Accepting Multinational Clinical Trials for Oncology Drugs?
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...Read More
FDA’s New Guidance on Decentralized Clinical Trials
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. Read More
