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Date Posted
News Title
2023/03/31
US: Guidance gives FDA authority to reject devices due to poor cybersecurity
2023/03/30
Australia: TGA gains new powers to reduce the impact of medicine shortages
2023/03/29
ICH: Expect “substantial” revision of ICH stability and specification guidelines
2023/03/28
US: FDA outlines plan for digital health technologies for clinical trials
2023/03/27
Europe: DARWIN EU ‘ramping up quickly’ with more partners coming on board
2023/03/24
US: FDA issues guidance on submission of pharmacogenomic data
2023/03/23
Asia: Pakistan gives manufacturers 30 days to update finished product specifications in online portal
2023/03/22
ICH: The ICH S12 Guideline reaches step 4 of the ICH process
2023/03/21
US: FDA finalizes guidance on suspect products under DSCSA
2023/03/20
Europe: EMA finalizes guidance on computerized systems and electronic data in clinical trials
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