FDA Framework Will Evaluate Use Of RWE To Support Labeling Changes

Through its new real-world evidence framework, FDA will evaluate how RWE can be used to support changes to labeling about a drug or biologic product’s effectiveness. Under the framework, FDA will assess various sources of real-world data, look at how it can fill in the gaps with more sources of RWD and issue more guidance documents to help sponsors who want to use RWE to support their work. The agency published its “ Framework for FDA’s Real-World Evidence Program ”...