FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications

FDA

8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics. 

The draft guidance is intended to get input on FDA’s proposal to encourage sponsors and applicants who are using RWD to generate real-world evidence (RWE) as part of a regulatory submission to identify in the cover letter that the submission contains RWE in a simple, uniform format. When implemented, FDA anticipates that this approach will allow FDA to identify and track RWE submissions, monitor outcomes and ensure appropriate relevant review expertise.

In December, the FDA issued a strategic framework for its RWE program, and ongoing work at the agency involving RWE includes foundational research to understand potential applications of RWE in regulatory decision-making. The agency plans to continue to engage the public and stakeholders around its work in this area, including a webinar held in March, as well as a workshop planned for later this year.

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Michael Wonder

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Michael Wonder