More than 300 COVID-19 Trials Reviewed by FDA’s New Drugs Office in 2020
Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office’s annual report shows it reviewed more than 320 trials for potential COVID-19 therapeutics and more than 570 drug development programs in the planning stages.
Ultimately, according to the report, OND contributed to the authorization of seven Emergency Use Authorizations for COVID-19 vaccines and treatments between March and December 2020, said Peter Stein, OND’s director.
OND also completed a restructuring initiative in 2020, creating eight new offices focused on broad therapeutic areas, such as neuroscience or immunology, and a new pharmacology/toxicology division that will evaluate nonclinical data for new drugs to aid in the selection of safe starting and maximum doses for first-in-human clinical trials and look for potential toxicities to monitor in clinical trials and assess toxicities not addressed in trials.
Read the OND annual report here: https://bit.ly/3tFtAgG.