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April 5, 2023
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD).
Rumi walks through:
- How FDA Reviews Combination Products
- Industry's role in shaping policy
- Essential Performance Requirements
- IMDRF and International Harmonization Opportunities
Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.