FDA Issues Real-World Evidence Framework for Drugs and Biologics

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From The National Law Review, December 2018

Summary

On December 6, 2018, Commissioner Scott Gottlieb announced the FDA’s highly anticipated new strategic framework for assessing the potential use of real-world evidence (RWE) in connection with the agency’s drug and biologic review program. The Framework follows a series of guidance documents, demonstration projects and other initiatives that FDA has already undertaken to explore and facilitate the use of real-world data (RWD) and RWE in the context of post-market surveillance activities, clinical trials and medical device regulatory decision making.

The Framework outlines key action items for FDA’s further assessment of the use of RWE and RWD and development of applicable standards that will be of interest to manufacturers, RWD companies and health care providers interested in harnessing RWD and RWE to enhance patient safety and treatment, and other stakeholders.

Description

From The National Law Review, December 2018

Summary

On December 6, 2018, Commissioner Scott Gottlieb announced the FDA’s highly anticipated new strategic framework for assessing the potential use of real-world evidence (RWE) in connection with the agency’s drug and biologic review program. The Framework follows a series of guidance documents, demonstration projects and other initiatives that FDA has already undertaken to explore and facilitate the use of real-world data (RWD) and RWE in the context of post-market surveillance activities, clinical trials and medical device regulatory decision making.

The Framework outlines key action items for FDA’s further assessment of the use of RWE and RWD and development of applicable standards that will be of interest to manufacturers, RWD companies and health care providers interested in harnessing RWD and RWE to enhance patient safety and treatment, and other stakeholders.

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