Thirty-five New Jobs as Spiddal Device Company Secures Investment From Helix Medical

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Biological Risk Evaluation and Management for Medical Devices

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Dec 11

ICH E6 GCP Interactive Workshop

Dec 12

Building a World-Class Advertising and Promotion Review Program

Dec 12

Transforming Quality Management with Modern Technology

Dec 18

Medical Device Voluntary Malfunction Disclosure Regulation: Are You Up to Date on the…

Dec 18

Medical Device Cybersecurity Risks & Best Practices: Navigating the Nuanced Cyber Regulatory Waters

Jan 10

Sampling Plans for Quality Audits

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Kyowa Kirin’s Poteligeo Gains European Marketing Authorization

Poteligeo is the first biologic agent targeting CCR4 to be approved in Europe.

FDA Releases Proposed Rule on De Novo Pathway for Novel Devices

FDA Commissioner Scott Gottlieb said the agency’s goal is “to make the De Novo pathway significantly more efficient and transparent.”