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nidan7500

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nidan7500

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Monday, 03/19/2018 11:21:35 AM

Monday, March 19, 2018 11:21:35 AM

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https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM082022.pdf

Any thoughts on what this new FDA process means going forward? For example; will the new Precision Medicine protocols and guidance/requirements result in a deeper and longer look at IND and NDA research data?
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