Webinar: Expedited US FDA Development and Approval Programs for Serious Conditions

Successfully navigate US FDA’s expedited programs for development of products for serious conditions: Understand the data expectations, planning .. Read more and timing skills, and authoring strategies to optimize the chance of securing an expedited program designation. The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program. This webinar will explain the differences between these programs, describe strategies to determine which program may be right for your product, and discuss FDA expectations and requirements for each program.