Is my drug or biologic eligible for one or any of the FDA expedited programs? How do I choose the right process? When do I qualify for a breakthrough? All these questions are answered during this webinar which begins with laying the foundation; first by helping you to understand what’s considered a “serious condition,” available therapies, and what defines an unmet medical need. Speakers will discuss FDA’s four expedited programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation, and then walk through which program is best suited to expedite and review a sponsor’s drug development and the different approaches for accelerating regulatory processes.
- +$100 for nonmembers
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Jeff Allen, Executive Director, Friends of Cancer Research
Tamy Kim, Director for Regulatory Affairs and Policy, Oncology Center for Excellence; Supervisory Director for Regulatory Affairs, Office of Oncologic Diseases, CDER, FDA
Miranda J. Raggio, Senior Regulatory Program Manager, Expedited Programs, Program Implementation and Development Management Staff, Office of New Drugs, CDER, FDA
Alexander J. Varond, Partner, Goodwin Procter LLP
Kathleen Winson, Executive Group Director, Product Development Regulatory, Roche Genentech
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