Making it Personal: Regulatory Challenges and Opportunities for Personalized Medicine Technologies in the United States

In recent years, medical science has become increasingly personal, focusing on matching individual patients to what may be the safest and most effective treatment for them. With this goal in mind, growing numbers of personalized medicine technologies, including therapies and diagnostics, are being developed and approved/cleared by FDA.

These include gene therapies, cell therapies, and products targeted to patients with specific biomarkers, as well as their associated companion and complimentary diagnostics. While these products are directed to smaller populations, they can provide both patients and sponsors with big opportunities. These opportunities, though, are not without regulatory challenges. Through this webinar, participants will learn about the current United States personalized medicine landscape, as well as FDA’s laws, regulations, and policies impacting this new and developing product category.