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 data from registries.