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- FDA issues early alert on Abiomed Impella controller safety issueThe FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
- Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacleRegulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models…