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Case Study – Labeling Review Case Study

Case Study – Labeling Review

Introduction The U.S. client is the manufacturer of IVDs and blood products. The client had created labeling in compliance with the US FDA labeling regulations for a new product. Business Challenge The internal team at the company had conflicting views on whether or...

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What You Need to Know About UDI’s Africa

What You Need to Know About UDI’s

General Context UDI is a Unique Device Identifier in the form of a unique number or alphanumeric code. It consists of plain text and AIDC (only readable via machine) Issued by an FDA-accredited issuing agency. UDI is granted for 3 years and can be renewed upon...

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Open FDA Initiative Case Study

Open FDA Initiative

What is the Open FDA Initiative? In June 2014, the U.S. FDA launched the “open FDA” a technology-driven initiative to make government information easily accessible to the public. The initiative was initially an order from the White House to implement a new...

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