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Regulatory Affairs Newsletter Archive

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance Page summary: The agreement between the government and the Association of British Insurers (ABI) on the use of genetic test results in underwriting insurance policies. Change made: First published. Code on Genetic Testing and Insurance: annual report 2023 Page summary: Annual report on agreement…
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January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. AI Safety Institute: overview Page summary: Find out about the AI Safety Institute. Change made: AI Safety Institute page added. Regulatory Horizons Council: Closing the Gap Series overview Page summary: RHC’s ‘Closing the Gap’ Series which aims to provide actionable insights and foster collaboration on solutions to address regulatory challenges.…
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January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Overseas business risk for Slovenia Page summary: Information on key security and political risks which UK businesses may face when operating in Slovenia. Change made: Information has been updated to provide the latest data, issued by the end of the 2023. UK takes action to boost supply chain resilience for…
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January 24, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 15 Jan)

FDA and CMS issue joint statement on LDTs Laboratory developed tests, or LDTs, help physicians make critical decisions about their patients’ care. According to the Center for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure…
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January 24, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
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January 24, 2024
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