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trding

02/23/17 11:49 AM

#11279 RE: pearsby09 #11277

I scanned through some of that yesterday, here is a quote from your last link that I really liked explaining the importance of BTD on page 10, https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf

Because FDA commits significant resources to work particularly closely with sponsors of breakthrough therapy products, the Agency needs to focus its resources on breakthrough therapy drug development programs that continue to meet the program’s qualifying criteria