The ins and outs of expedited approvals for drugs and devices: how to qualify, FDA expectations, initiating discussions, securing benefits.
FALLS CHURCH, VA. (PRWEB) JULY 23, 2019
Secure and Accelerate Product Approvals
Reap the Rewards of FDA’s Breakthrough Designations
**An FDAnews Webinar**
Tuesday, July 30, 2019, 1:30-3:00 p.m. EDT
https://www.fdanews.com/productapprovals
Take advantage of the expedited FDA approval programs for drugs and devices. Understand what it takes to qualify and how to secure the benefits to make a big difference in the bottom line.
Join FDA legal experts Greg Levine, Esq. and Kelly Combs, Esq. as they clarify it all. Both are partners in the life sciences practice group at Ropes & Gray LLP, with Mr. Levine as co-chair.
Attendees will learn the various programs’ unique eligibility criteria, distinctive benefits and when to pursue each in the product-development timeline to reap potentially significant rewards.
This webinar will help attendees and team members:
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
Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.
Webinar Details:
Secure and Accelerate Product Approvals
Reap the Rewards of FDA’s Breakthrough Designations
**An FDAnews Webinar**
Tuesday, July 30, 2019, 1:30-3:00 p.m. EDT
https://www.fdanews.com/productapprovals
Tuition:
$287 per site
Easy Ways to Register:
Online: https://www.fdanews.com/productapprovals
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.
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