Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations
XTalks
MAY 13, 2022
The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case. FDA prefers the use of DEREK, a knowledge-based expert system for the qualitative prediction of toxicity, and SARAH, a statistical software to identify potentially toxic chemicals for assessment of genotoxic and sensitization potential.
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