New premarket submission route: FDA’s eSTAR Program
Originally Published on January 12, 2023 by Sebastian Feye In September of 2018, the FDA took their first step to…
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Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development
Originally Published on April 22, 2021 by Sebastian Feye Acronyms: TPLC – Total Product Lifecycle AI/ML- Artificial Intelligence and Machine…
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An Overview of FDA Inspections across Drugs, Biologics and Medical Devices
Originally Published in November 18, 2020 by Sebastian Feye The Food and Drug Administration (FDA) primary responsibility is the enforcement…
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