5 Key Rules for Regulatory Science
What is Regulatory Science? It’s science-based analysis of a medical product. This includes assessing benefits versus risks, determining how to develop valid scientific evidence of effectiveness and safety, and addressing certainty versus uncertainty in the data. Regulatory Science bridges the gap between innovation and patient access by ensuring that product development includes rigorous yet reasonable testing strategies. Regulatory Science is also science-based advocacy for a medical product. It helps tell the story about how the data supports the safety and effectiveness of the product. It also works with product development and regulators to align regulatory expectations. Here are our five key rules for good Regulatory Science.
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