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Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Agency IQ

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

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Diabetic eye disease: The urgent need for early, non-invasive treatments

Drug Discovery World

Marketed anti-VEGF therapeutics effectively neutralise retinal VEGF levels and reduce both vascular leak and consequential oedema, resulting in a temporary improvement in vision, but do nothing to address the underlying pathology – capillary drop-out 5. million by 2029, according to GlobalData. In 2019 there were >14.2

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Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. Once the E.U.

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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

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The politics of health: How 2024 elections will impact life sciences

Drug Discovery World

While the shadow of the pandemic recedes, its effects linger in the form of a market correction and an evolving healthcare landscape. The strategy is aimed at keeping the sector competitive in a country that has recently been struggling to maintain relevance in the global medical device and clinical trials scenes.

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