Expert recommends alternative approaches to substitute for randomized trials for COVID vaccines | RAPS
Regulatory NewsJoanne S. EglovitchArtificial intelligence/machine learning (AI/ML)Biologics/ biosimilars/ vaccinesChemistry, Manufacturing and Controls (CMC)Clinical TrialsCoronavirus/COVID-19Product developmentRegulatory Intelligence/PolicyRegulatory strategySubmission and registrationUnited StatesUS Food and Drug Administration (FDA)