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Newsletter - March 22, 2018
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FDA Posts Full Clinical Study Report for NDA for Novel Products 

This week FDA posted a full clinical study report (CSR) included in an NDA approved last month for prostate cancer drug ERLEADA. In this new pilot transparency program FDA plans to similarly publish CSRs for eight more newly approved drugs aiming to provide more usable information about clinical trial design, statistical analysis.. Read More

How Binding Are the FDA Guidance Documents? DOJ Says, Not Much

 
Earlier this year, the Associate Attorney General at the Department of Justice (DOJ) instructed its staff to not initiate civil enforcement action against any party based on Guidance Documents, a decision that can have an enormous impact on the FDA regulated industry..Read More

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