Newsletter - June 8, 2023
FDA Puts Its Weight Behind Virtual Clinical Trials
Decentralized or Virtual clinical trials have emerged as a game-changing approach to study the efficacy and safety of new treatments and interventions. But the regulatory expectations from these trial designs were not clarified. That is, till now. With two guidance documents released within the last month, the FDA...Read More
FDA Definition of Generally Accepted Scientific Knowledge: Will It Reduce Animal Studies?
In its ongoing efforts to show how sponsors of market approval applications can provide alternate data to reduce non-clinical studies, FDA released a guidance describing Generally Accepted Scientific Knowledge (GASK) which can be used in lieu of animal studies. In the process, FDA also highlighted how subjective...Read More
FDA Puts Its Weight Behind Virtual Clinical Trials
Decentralized or Virtual clinical trials have emerged as a game-changing approach to study the efficacy and safety of new treatments and interventions. But the regulatory expectations from these trial designs were not clarified. That is, till now. With two guidance documents released within the last month, the FDA...Read More
FDA Definition of Generally Accepted Scientific Knowledge: Will It Reduce Animal Studies?
In its ongoing efforts to show how sponsors of market approval applications can provide alternate data to reduce non-clinical studies, FDA released a guidance describing Generally Accepted Scientific Knowledge (GASK) which can be used in lieu of animal studies. In the process, FDA also highlighted how subjective...Read More
