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 improve and modernize the process...
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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 learning SaMD – Software as...
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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 of the Federal Food, Drug...
Read MoreNew Medical Device Pathway: Safety and Performance Based Pathway
Originally Published in August 31, 2020 by Sebastian Feye In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially...
Read MoreOver-the-Counter (OTC) Drug Monographs Reform Summary
Published Originally in June 22, 2020 by Sebastian Feye Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not...
Read MorePart 11 compliance is critical, Firms need to be aware of compliance with using the Cloud
Posted originally December 10, 2019 by Sebastian Feye 21 CFR Part 11 – Electronic Records Part 11 of the Code of Federal Regulations applies to...
Read MorePwC Risk Strategy and Emerging Technologies
Posted originally July 31, 2019 by Sebastian Feye Today I had the opportunity to listen into a PricewaterhouseCoopers (PwC) webinar hosted by SDRAN discussing how...
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