Global biopharma companies are increasingly using RWE to strengthen regulatory submissions.
Aetion’s new eBook is designed to help inform your RWE strategy, guiding you through when, where, and how RWE studies have supported FDA approvals for new drugs and biologics.
In addition, learn from deep dives into two external control arms submitted to support FDA approvals—one which provided substantial evidence and one with design limitations—and see how you can apply the takeaways to generate high-quality RWE studies.
Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated RWE on the safety, effectiveness, and value of treatments.
FDA Commissioner Dr. Stephen Hahn states that the FDA’s collaboration with RWE partners like Aetion is reflective of the “FDA’s commitment to good science and rigorous data… [as] the basis for decision-making.”