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Regulatory Affairs Newsletter Archive

Proposal for new ISO Technical specification on sequencing and clinical application to infectious diseases Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Proposal for new ISO Technical specification on sequencing and clinical application to infectious diseases

The BSI CH/212 IVDs group is responsible for standardization in the field of in vitro diagnostics (IVDs). They have put forward a proposal to develop a new technical specification, ISO/PWI TS 8219: Sequencing and clinical application to infectious diseases. The document covers the essential requirements for advanced sequencing procedure for detecting the microbes directly, without the need for microbial culture.…
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August 4, 2023
MHRA weekly update (WC 24 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Guidance updated to reflect the latest information regarding the MORE portal. COVID-19 test validation approved products Page summary: Find out which…
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August 4, 2023
DHSC weekly update (WC 24 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance: call for evidence* Page summary: We are seeking views on the Code on Genetic Testing and Insurance, to help us decide whether it may need to be revised to ensure it remains beneficial to both consumers and the insurance industry. Change made: First published.…
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August 4, 2023
DBT weekly update (WC 24 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Joint outcome statement: UK-India round eleven FTA negotiations Page summary: Round eleven of negotiations for a free trade agreement between the United Kingdom and the Republic of India Change made: First published. Training on export control compliance Page summary: Courses, seminars, workshops and webinars to help exporters understand their obligations…
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August 4, 2023
DSIT weekly update (WC 24 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Research Ventures Catalyst: open for applications Page summary: A pilot programme that will stimulate the creation of novel research ventures, via entrepreneurial team-based approaches in collaboration with partners drawn from the public sector, industry and the third sector. Change made: Research Ventures Catalyst open for applications question and answer document…
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August 4, 2023
U.S. FDA weekly update (WC 24 July) FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 24 July)

Please note this is an extract of the original bulletin. For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and…
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August 4, 2023