Exploring FDA’s Expedited Programs: Applicability and Eligibility
ACI’s 41st FDA Boot Camp
Sep
20
2023
Date: September 20, 2023
Time: 10:45AM (EST)
Location: Boston, MA
Mintz Of Counsel Ben Zegarelli spoke at the American Conference Institute's 41st FDA Boot Camp leading the session "Exploring FDA’s Expedited Programs: Applicability and Eligibility". The session covered the following:
- Evaluating the criteria for eligibility, benefits, and limitations of each program
- Understanding accelerated approval, surrogate and intermediate clinical endpoints
- Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs
- Reviewing priority review
- Factoring expedited programs into your drug development strategy
- Discuss recent changes to FDA’s Accelerated Approval program
Speakers
Benjamin M. Zegarelli
Speaker
Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.