The Weinberg Blog How to Ensure Your Device, Software, and Drug Are Ready for a Pre-Approval Inspection

When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a manufacturing facility named in an application can manufacture the product, and that the submitted data are accurate and complete. Ultimately, the purpose of […] The post How to Ensure Your Device, Software, and Drug Are Ready for a Pre-Approval Inspection appeared first on The Weinberg Group.