Expedited US FDA Development and Approval Programs for Serious Conditions

The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately.  Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program.

This webinar explains:

• • Differences between these programs
  • Strategies to determine which program may be right for your product
  • FDA expectations and requirements for each program