The US FDA’s formal guidance on development of COVID-19 treatments and preventative agents takes a broadly flexible approach to Phase 2 and 3 trial design, repeatedly indicating a willingness to consider varied options while urging sponsors to discuss their trials plans with the agency earlier rather than later.
“FDA is committed to supporting all scientifically sound approaches to attenuating the clinical impact of COVID-19,” the guidance declares. At the same time, however, the agency seeks rigorous clinical evaluations that meet traditional regulatory standards, ideally with placebo controls, randomization and double blinding.
The final guidance, issued on May 11, 2020, focuses on… Read more »
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