Updates on the FDA’s Recent RWE Guidance
On demand RWE sessions
Regulatory experts share their interpretations of recent FDA guidance
If you want to learn more about the FDA’s latest RWE draft guidance you may be interested in listening to FDA RWE guidance is here…what next for interpretation and implementation?
This panel is comprised of four RWE experts who have a combined 16+ years of experience working at the FDA and were involved in responding to each of the documents. During this session they will discuss the interpretation and implementation of this draft guidance with respect to study design, data standards and quality and policy as they consider opportunities for life sciences industry members moving forward.
Explore these additional resources
In “New FDA draft guidance document gets real about RWD,” Outsourcing Pharma explores the nuances in the FDA’s draft guidance with two IQVIA real world evidence experts.
In this Pharmaceutical Commerce podcast, IQVIA Vice President of Real-World Solutions Matthew W. Reynolds dives into the implications of the FDA’s recent draft guidance, specifically looking at using real-world data from EHRs and medical claims data to aid in drug development and regulatory decision-making.
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