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The 21st Century Cures Act & Regenerative Medicine: Understanding the Connection
Want to attend the live webinar on March 2? Click here to register.
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 and Kelly Lightfoot Feuer — both of Fuerst Ittleman David & Joseph, PL — as they examine the potential impact of the 21st Century Cures Act and related developments on regenerative medicine.
After this 90-minute session you’ll learn:
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.
Meet Your Presenters
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.
Kelly Lightfoot Feuer, Regulatory Attorney, Fuerst Ittleman David & Joseph, PL’s Food, Drug, and Life Sciences Practice Group
Kelly Lightfoot Feuer focuses her practice in the areas of food, device, and drug law, assisting clients regulated by the U.S. Food and Drug Administration, the Federal Trade Commission and other federal, state and local authorities.
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