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Secure and Accelerate Product Approvals: Reap the Rewards of FDA’s Breakthrough Designations
Join FDA legal experts Greg Levine, Esq. and Kellie Combs, Esq. as they clarify the advantages of qualifying for an expedited FDA approval program, what it takes to qualify and how to secure the benefits.
Understand how the various programs — Priority Review, Accelerated Approval, Fast Track, Breakthrough Therapy, and Breakthrough Devices — each have unique eligibility criteria, distinctive benefits and must be pursued at different times in the product-development timeline to reap potentially significant rewards.
Presentation Takeaways:
- Expedited approval programs for drugs and biologics, including highlights from the 2014 FDA guidance
- Explore eligibility criteria
- Get clarity on program features and benefits
- Understand timing and content considerations for designation requests and applications
- How to qualify for multiple programs
- Breakthrough devices program, including highlights from the 2018 guidance
- Discover designation criteria, including data generation requirements
- Get clarity on program features and benefits
- Determine timing and content considerations for designation requests
- Understand the designation review process
- Hypotheticals and real-world examples regarding eligibility for expedited programs
Learn how earlier and more frequent FDA interactions, streamlined clinical development requirements, and a shorter FDA review clock may all accelerate time to market… and improve your bottom line.