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Most Recent Articles
Business Development Insights from Medical Device Safety and Quality Data
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices, Advancing the Ability to Manage and Share Device Product Data
You Missed the Drug Listing No Change Certification Deadline…Now What?
If a drug product listing was not updated or certified in 2017 as containing no changes to the information on file, it has now been flagged in the NDC Directory as an uncertified product.
Webinar: FDA's No Change Certification for Drug Products
FDA’s New Drug Product Listing Blanket No-Change Certification
Now, in addition to submitting updates to any product listings as they occur, drug product companies must submit a Blanket No Change Certification during the annual reregistration period.
A Joint Solution: Manage & Syndicate Device Product Data with Reed Tech & 1WorldSync
Manage & Syndicate Medical Device Product Data with Reed Tech & 1WorldSync
Webinar: UDI and the EU MDR: What You Need to Know
Reed Tech Life Sciences and PRISYM ID team members discuss Unique Device Identification in the EU.
Webinar: FDA Annual Reporting Period for Drug Products
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