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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…
admin
January 24, 2024
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Recently published EU/UK standards/regulations

Multiple EU/UK standards/regulations updates have been published recently. Notably, these include: European Union (Withdrawal) Act 2018 The Environment Act 2021 (Commencement No. 8 and Transitional Provisions) Regulations 2024: These Regulations bring into force provisions of the Environment Act 2021 (c. 30) (“the Act”). These are the eighth commencement regulations made by the Secretary of State under the Act. These Regulations…
admin
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…
admin
January 24, 2024
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