TEST: Regenerative Medicine: Steps to Accelerate Development
With the 21st Century Cures Act, attention is being focused on the use of human cells and tissue to treat serious and underserved conditions.
The FDA created a new regulatory paradigm in November 2017 when it issued four guidances — 2 final and 2 draft — aimed at explaining, streamlining and accelerating development of regenerative therapies.
Key among these developments is the creation of a new Regenerative Medicine Advanced Therapy (RMAT) designation that offers applicants an abbreviated pathway to approval, working closely with the FDA throughout the process.
Regenerative Medicine outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify. The FDA granted RMAT designation to 12 organizations in 2017 — the first year of the program. Now is the time to get in the mix, work with the FDA to develop the program and improve your chance of being one of the next RMAT designees.
You will learn:
- Key definitions the FDA uses in evaluating regenerative medicine applications
- Requirements to be eligible for RMAT designation
- How to apply for RMAT designation
- How the final versions of the Same Surgical Procedure and Minimal Manipulation guidances differ from their drafts
Order your copy of Regenerative Medicine: Steps to Accelerate Development and learn what it takes to get in on the ground floor of the new approval pathway and use it to accelerate your road to market.
Who Will Benefit
- Regulatory affairs
- Quality control
- Legal professional
- Business affairs professionals
November 9, 2018