Clinical R&D Resource Center

FDA Issued Clinical Trial Guidance for COVID-19

FDA issued clinical trial guidance, though ‘Unavoidable’ protocol deviations are anticipated The U.S. Food and Drug Administration (FDA) issued clinical trial guidance last week for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. The FDA recognizes that the COVID-19…

FDA Announces Maximal Usage Trial for Active Ingredients

Standard approach to assessment of drug products (The following is a direct release from the U.S. Food and Drug Administration.) The U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled “Maximal Usage Trials for Topically Applied Active…