Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions
The FDA’s CDER Metrics program is set to launch early next year. Although this initiative is voluntary in 2018, it signals a new direction for how the FDA will approach future compliance and inspection practices. A risk-based, data-driven approach will become key to ongoing compliance and success. It’s important to understand and prepare for the upcoming CDER Metrics initiative even if you’re not yet ready to participate.