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Regulatory Affairs Newsletter

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 18 Dec)

FDA publishes a draft guidance on Real World evidence FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World…
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December 20, 2023
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ISO 13485 Stakeholder Feedback Survey

In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016. The technical committee have launched a survey seeking feedback on the use of the standard for regulatory…
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December 20, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Advanced manufacturing plan Page summary: The advanced manufacturing plan sets out the actions we are taking to be the best place in the world to start and grow a manufacturing business. Change made: HTML version of the Advanced Manufacturing Plan added to document list. Time updated: 11:47am, 6 December 2023…
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December 15, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Landmark moment for scientists, researchers and businesses as UK association to £80 billion Horizon research programme officially sealed Page summary: The UK’s association to the world-leading Horizon and Copernicus programmes has been officially sealed today (Monday 4 December), as Science and Technology Secretary Michelle Donelan visits Brussels to turbo-charge efforts…
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December 15, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Government response to the review into commercial clinical trials Page summary: The full government response to the Lord O’Shaughnessy independent review of UK commercial clinical trials. Change made: Added Welsh version. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to…
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December 15, 2023
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