Overview Of FDA's Expedited Program For Serious Conditions

Many serious and life-threatening diseases in the United States currently lack effective treatments. As researchers develop innovative therapies, including those in regenerative medicine, it's crucial to get these treatments to patients as quickly as possible. This is where the FDA's expedited review programs come in. Programs like Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Regenerative Medicine Advanced Therapy (RMAT) Designation are essential for helping promising new drugs reach the market faster.

This webinar explains what these expedited review programs are, what incentives they provide, and what information you need to successfully apply for one of these designations.

After this presentation, you will be able to:

• Define key terms related to the FDA's expedited review programs: FTD, BTD, and RMAT.
• Explain the requirements and benefits of a successful FTD, BTD, and RMAT application, and when to submit these applications to the FDA.
• Recognize how these expedited review programs reduce the time it takes to develop and approve new drugs.