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Recent FDA Approval Trends – What You Should Know

  May 01, 2013  
Center for Professional Innovation & Education, Inc., Berlin, Germany
Nov. 4 & 5, 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

Organized by: Center for Professional Innovation & Education
Invited Speakers:  Contact info@cfpie.com for a list of course instructors
Deadline for Abstracts: n/a
Registration: http://www.cfpie.com/showitem.aspx?productid=131&source=hummolgen
E-mail: info@cfpie.com
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