FDA Urges Sponsors To Study COVID-19 Drugs In Randomized Trials

FDA is urging drug and biologic sponsors to study potential COVID-19 drugs in randomized, placebo-controlled trials that include high-risk individuals and patients with renal impairment, according to a Monday (May 11) guidance document. The agency also wants sponsors to ensure racial and ethnic minorities and elderly people, as well as those with high-risk conditions, are represented in clinical trials. The guidance is one of two that FDA published on Monday that aim to get studies for potential COVID-19 drugs and...