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• FDA's
• Lisa Henderson, Editorial Director of Pharmaceutical Executive and Todd Phillips, Pharma D Director of Regulatory Affairs and ...
• Callie Cappel-Lynch from CDER's Office of New Drugs discusses processes, requirements, and best practices for PDUFA ...
• Learn the complete step-by-step process of
• CDER's Judit Milstein and Maureen Dillon-Parker discuss the sponsor's responsibilities for an active IND and available agency ...

In-Depth Information on Understanding Fda Expedited Programs

For the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the Todd Phillips, Principal Scientist with Cardinal Health Regulatory Sciences, provides advice on steps biopharma companies ... Fast Track Designation and Accelerated Approval are two of the most important Successfully navigate US

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