Leveraging FDA’s Expedited Programs: Now and in the Future
Diane Beatty, PhD, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences
Todd Phillips, PharmD, RAC, Principal Scientist, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences
FDA is committed to advancing the development of therapies that treat serious conditions and rare diseases. As part of this commitment, FDA offers expedited programs for biopharmaceutical companies to reduce development and review timelines for new drugs and biologics that address unmet medical needs.
In this webinar, Cardinal Health regulatory experts will examine FDA’s four expedited programs—fast track designation, breakthrough therapy designation, accelerated approval pathway and priority review designation—and their impact on recently approved products indicated for serious conditions and rare diseases. Our experts will also explore how the 21st Century Cures Act will impact future requests for expedited program designation and utilization.
- FDA regulations governing expedited programs
- Differences between the four expedited programs
- Qualifying criteria and features of each program
- Requirements and best practices for requesting designation
- Leveraging expedited programs to support the development of orphan designated products
- Implications of the 21st Century Cures Act on expedited programs
Who Should Attend:
VP, Director or Manager level professionals in the following fields:
- Regulatory Affairs
- Research and Development
- Clinical Research
- Medical Writing
- Quality and Manufacturing
- Quality Assurance
About the Sponsors
For 40 years, Cardinal Health Regulatory Sciences has been delivering proven regulatory consulting expertise to help pharmaceutical, biotechnology and medical device companies obtain global product approval and maintain filings throughout the entire product lifecycle. Our experts have provided support for more than 100 approved products and have experience in all therapeutic areas.For more information please visit www.cardinalhealth.com.