Center for Professional Innovation & Education, Inc., Los Angeles, CA
July 22 & 23, 2013
This course is specifically designed to provide details regarding the relevant trends for FDA approvals and, additionally, discusses the factors determining these trends and potential implications for the future. Among the topics presented are: Basic approval trends for NMEs, NDAs, BLAs and Supplements
Special Product Designations/Programs such as Orphan Products
Regulatory science and ‘Next Wave’ product approvals
Impact of FDA and Sponsor workload on approval trends
Factors that may introduce bias into the approval process
What PDUFA’s past tells us about PDUFA’s future
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