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Oral Poster Session 4 - Regulatory Science & Value and Access Content Hub
Learning Objective : The aim of our study was to understand the current status and trends of the Breakthrough Designation (BTD), PRIME and SAKIGAKE expedited review programs regarding number of reviews, most benefited therapy areas, drugs reviewed, profile of applicants and time to regulatory approval.
Speaker(s)
An overview of the current status and trends in the Breakthrough Designation, PRIME and SAKIGAKE expedited review programs
Pedro Borga, MPharm
Lifescience Dynamics Ltd, United Kingdom
Consultant
Early Actions granted by FDA: a review of the frequency and importance of NDA/BLA approvals in advance of DUFA action date
Camille Metais, MSc
Alexion Pharma GmbH, Switzerland
Senior Director Regulatory Affairs
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