Expedited US FDA Development and Approval Programs for Serious Conditions
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 explains:
- Differences between these programs
- Strategies to determine which program may be right for your product
- FDA expectations and requirements for each program
David Shoemaker, Ph.D.
Senior Vice President, Research & Development
Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas. Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities. At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents…
Genna Kingon, Ph.D., RAC
Associate Director, Regulatory Strategy
Dr. Genna Kingon, Associate Director, Regulatory Strategy, has participated in and contributed to the regulatory strategy and submission management from pre-IND to post-approval. Her experience includes leading teams for a 505(b)(1) program for a BTD product, including management of the study-level biostatistics and programming activities and CSR development for the Phase 3 program through NDA submission-readiness. Also, she serves as the program director leading multi-disciplinary teams in the strategy, management, and development of multiple INDs/IDEs and associated marketing application activities for a portfolio of related products. With over a decade of experience in scientific writing and editing clinical and nonclinical…