The US Food and Drug Administration’s recent guidance on assessing electronic health records and claims databases to support regulatory decision-making should better distinguish between these two types of real-world data sources, stakeholders said.
Real-World Data: FDA Urged To Distinguish Between Electronic Health Records And Medical Claims
Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.
