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CRO Articles From Our Team

Our Resource Center has been painstakingly developed by our experts to give you the most up-to-date, pertinent information to help you through your regulatory pathway. While we would love the opportunity to work with you, we hope this Center helps you find answers and direction.

Postmarketing Safety Reporting for Combination Products

Resource CenterWhat Does FDA Consider a Combination Product? Accordingly, the U.S. Food and Drug Administration (FDA) defines a combination product that is composed of any combination of a drug and a device; a biological product and a device; a drug, device, and a...

The FDA Launches a Digital Health Center of Excellence

Resource CenterDigital health technology has revolutionized the healthcare field, affording new patient care techniques and increased patient control. The FDA’s new Digital Health Center of Excellence establishes digital health as one of the agency’s central focuses...

Post-Market Medical Device Requirements

Resource CenterMedical devices inevitably possess risk, so manufacturers should continue to evaluate their products after they reach the market. By creating an effective post-market surveillance plan, you can increase user safety and satisfaction.What is post-market...

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