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
David Shoemaker, Ph.D.
Senior Vice President, Research & Development
Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing…
Genna Kingon, Ph.D., RAC
Associate Director, Regulatory Strategy
Dr. Genna Kingon, Associate Director, Regulatory Strategy, has participated in and contributed to the regulatory strategy and submission…