Entries from HEALTH LAW SECTION BLOG tagged with 'Japan'

Human Clinical Trials,Marketing Authorization for Pharmaceuticals-ICH

From FDA/CBER, Sept 4, 2008, a follow up on an ICH Harmonised Tripartite Guideline document, 'Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals' (M3(R2) Current Step 2 version dated 15 July...

FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and...

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