Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization
FDA is issuing (Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization) guidance to provide recommendations to sponsors on the development of monoclonal antibody (mAb) products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19, including recommendations on addressing the impact of emerging variants.
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products guidance provides considerations for sponsors proposing to design a new registry or use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. This guidance does not provide recommendations on choice of study design or statistical methods used to analyze […]
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of […]