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Regulatory Affairs Newsletter Archive

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

DBT weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Conformity assessment and accreditation Page summary: Guidance for business and government departments. Change made: DBT and DHSC agreed joint policy statement added. Reference Documents for The Customs Tariff (Preferential Trade Arrangements) (EU Exit) Regulations 2020 Page summary: Find the UK’s preferential tariffs and Rules of Origin for the agreements contained…
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January 17, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices. Change made: Added ‘Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices’ and information about ‘future core regulations’. Regulatory…
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January 17, 2024
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