Secure and Accelerate Product Approvals - Webinar Recording/Transcript

$287.00
Quantity Discounts
1 - 2
$287.00
3 - 4
$258.00
5 - 6
$244.00
7 - 9
$230.00
10 - 9999
$215.00

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.

  • Regulatory affairs
  • Research and development
  • Legal counsel

Meet Your Presenters

Greg Levine, Esq. is a partner and co-chair of the life sciences practice group at Ropes & Gray LLC. His practice is focused on FDA regulation of pharmaceuticals, biotechnology and medical devices. He regularly represents such clients before state and federal regulators in all phases of the product lifecycle, assisting with internal and government compliance investigations and enforcement actions. Mr. Levine also advises manufacturers of other FDA-regulated products — including cosmetics and dietary supplements — on a broad range of issues under the Food, Drug, and Cosmetic Act and related laws.

Kellie Combs, Esq. is a partner in the life sciences practice group at Ropes & Gray LLC. She provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Ms. Combs routinely advises clients on advertising and promotion, lifecycle management, regulation of clinical research and post-approval compliance. She also conducts regulatory due diligence in connection with transactions involving drug, device, dietary supplement, cosmetic and other consumer product manufacturers, and she has advised on a number of government investigations of FDA-regulated companies.