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Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Agency IQ

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

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Considering the use of animal models in drug development

Drug Discovery World

Professor Andy Whiting , CEO of Nevrargenics, asks whether animal models should be used as the default regulatory requirement and explores the times to use them. Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. The sector (regulators, industry, researchers et al.)

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The global preclinical CRO market was estimated to be valued at US$5.7 What is a Pre-Clinical CRO?

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Read AgencyIQ’s analysis of those exemptions here.

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Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Agency IQ

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. The final rule is expected in April 2024. BY PATRICIA ISCARO, ESQ. |

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Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.