Exploring FDA’s Expedited Programs: Applicability and Eligibility

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