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Re: None

Monday, 11/24/2014 8:36:35 PM

Monday, November 24, 2014 8:36:35 PM

Post# of 422607
OFFICE OF NEW DRUGS Developing Indication-Specific Guidance, the first run of drug development IMO will contain guidance on CV treatments. This however, doesn't address SPA's which where developed to prevent the moving bar...and Congress wants an answer.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM073016.pdf
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