FDA Law Blog
FEBRUARY 9, 2024
Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. Whereas if the DHT meets the device definition and is used outside of a clinical investigation, full compliance with design controls requirements is applicable.
FDA Law Blog
OCTOBER 6, 2022
Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).
GeriPal
MAY 5, 2022
We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. And honestly in undergrad I was like, “Engineering is really hard. Five big manufacturers.
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