Unique Device Identification (UDI) will bring about a “huge global change” in the way medical devices are tracked and identified, Amy Fowler told MD&M Minneapolis conference attendees. Fowler, who serves as principal advisor, regulatory affairs...
FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.FDA has issued its proposed rule that would require most medical devices distributed in the United States to bear a unique device identifier (UDI). FDA believes that...
Several packaging chapters within the U.S. Pharmacopeia—including some mandatory ones—are now being revised and updated, which could significantly influence pharmaceutical packaging development and specifications (tests, methods, and acceptance...
With the emergence of drug serialization requirements in life sciences over a decade ago, many manufacturers embarked on ad hoc pilot projects to identify potential difficulties. Many of those projects lacked adequate funding and saw potential...
Sanofi Pasteur’s serialization program will be detailed during Pharmapack North America on June 10. Attendees will learn about Sanofi Pasteur’s approach as well as the program’s impact and best practices directly from John Woodburn, North America...
