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Most Recent Articles
Reed Tech Navigator™ for Medical Devices Recognized with a 2017 Connectiv Innovation Award
The Connectiv Innovation Awards recognize ground-breaking innovations bringing solutions to challenges seen within the B2B space.
FDA Changes the Process for Drug Product Listings with No Updates
There are significant changes coming to the FDA’s electronic Drug Registration and Listing System (eDRLS) that require action from most drug labelers before the end of the year.
UK NHS eProcurement: The What, Who, Why and When
eProcurement is a requirement for any organization doing business with an NHS care provider. For most device companies operating in the U.K., NHS is by far the largest customer in that market.
Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)
FDA’s Class I extension is about ensuring GUDID data quality and submission accuracy, not about giving industry time to work on other projects.
Structured Product Labeling, Eh? Health Canada’s SPL Pilot
Health Canada is working with volunteer manufacturers and sponsors, as well as technology vendors, to test the application of the HL7 SPL standard to the content of drug product monographs.
FDA Insight: UDI Data Quality
Why Data Accuracy in Drug Listings is Essential
This month, FDA issued a warning letter to an OTC drug labeler for failing to provide complete and accurate information in the metadata sections of two drug listing files.
Despite Extension, 2017 UDI Deadline Still Holds for Certain Contact Lenses
FDA delayed the UDI deadline for soft contact lenses to a future undetermined date but the September 24, 2017 deadline for rigid, gas-permeable contact lenses remains unchanged.
Reed Tech Introduces GDSN Capabilities in Collaboration with 1WorldSync™
The Reed Tech Life Sciences Team is pleased to announce that we are now offering a full-service solution to allow medical device organizations to share product data through the GDSN.
Zoom In: A Closer Look at Device Safety Data
There is a staggering amount of medical device safety data available from U.S. government sources. Where can we find it? What can it tell us?
In the Spotlight: Medical Device Safety and Quality Events
UDI Update: New FDA GUDID Technical Documents Released
FDA sent an email to its list of UDI GUDID email subscribers with updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation Files.
Reed Tech® Introduces Reed Tech Navigator™ for Medical Devices
Navigator is a new analytics and research solution that makes it easy to analyze and compare the safety and quality of tens of thousands of medical device products.
Drug Product Annual Reporting Periods
GDUFA and Self-Identification: What’s changing? (And What’s Not?)
GDUFA requires sites engaged in certain generic drug activities to self-identify annually prior to paying a user fee set by the agency.
FDA’s Electronic Drug Listing Requirements for Manufacturers
National Drug Code (NDC) Assignment Guide eBook
GS1, GTIN, GDSN--What do they have to do with UDI?
If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, like “GS1,” “GTIN” and “GDSN.”
UDI Data Security: Why it should be important to you
Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio.
Data Submitted! But the UDI Journey Continues...