Scrip Regulatory Affairs
Shared responsibility in medical device safety and performance
10 September 2010
Michael Cheng
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NEWS
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- EU guidance could jeopardise confidentiality, says industry, but consumers want more openness
- Draft EU regulation sets out uniform conditions for various pharmacovigilance activities
- US PDUFA V deal adds 60-day cushion for new drug, biologic reviews
- ICH to clarify E3 guideline on clinical study reports and alignment with CTD
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ANALYSIS
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FEATURES
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COMMENT
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