The 21st Century Cures Act & Regenerative Medicine: Understanding the Connection
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation.
If RAT designation is achieved the product becomes eligible for priority review by the FDA. The 21st Century Cures Act offers an opportunity for regenerative medicine to bypass the time consuming hurdles on the way to meet patient needs.
Join Andrew S. Ittleman of Fuerst Ittleman David & Joseph, PL as he examines the potential impact of the 21st Century Cures Act and related developments on regenerative medicine.
After this 90-minute session you’ll learn:
What provisions of the 21st Century Cures Act directly impact the regenerative medicine industry, and why the Executive Director of Regenerative Medicine Foundation said that regenerative medicine is “taking its place” for the time.
How the legislation creates new conditional pathways and shortcuts to approval for regenerative medicine products, and what you need to know to avail yourself of them.
What is a Regenerative Advanced Therapy (RAT) and what FDA requires for a RAT designation when seeking approval for a regenerative medicine product.
How to submit a RAT designation request and the types of submission information FDA requires.
The key terms impacting regenerative medicine regulation, including “minimally manipulated,” “homologous use,” “not manufactured by combining ells or tissues with another article,” and “not having a systemic effect.”
How the 21st Century Cures Act accelerates and drives approvals for RAT.
The importance of the provision in the 21st Century Cures Act requiring FDA to report to Congress on how many regenerative advanced therapy applications are received and granted.
How FDA’s Center for Biologic Evaluation and Research has been reorganized to better regulate regenerative medicine, including the creation of FDA’s newly created Office of Tissues and Advanced Therapies (OTAT).
The history of FDA’s regulation of the regenerative medicine industry.
Order today and learn about the upcoming changes to regenerative medicine brought about by the new statutes and become aware of issues to watch for in 2017 and beyond.
Andrew S. Ittleman, Founder and Partner, Fuerst Ittleman David & Joseph, PL
Andrew Ittleman concentrates his practice in the areas of white collar criminal defense, anti-money laundering compliance and food and drug law. Mr. Ittleman litigates extensively against the United States government in civil and criminal matters.