UDI Submission Load Testing
As I talk to medical device industry members about their plans for UDI, I continue to find many organizatio...
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Drug Product Annual Reporting Periods
GDUFA Self-Identification: What Generic Companies Need to Know
Reed Tech subject matter expert Jon Nolan talks GDUFA and Self-Identification during a webinar March 8, 2017.
UDI & GDSN Webinar - Making the most of your GUDID Data
GDSN expert Peter Alvarez of GS1 and UDI expert Gary Saner of Reed Tech discuss how medical device labelers can utilize the Global Data Synchronization Network (GDSN) to capitalize on their investment
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.
Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync
This agreement will allow Reed Tech customers to access the Global Data Synchronization Network (GDSN) and provide 1WorldSync customers with expanded options for managing their regulatory data.
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 Post-GUDID Publishing Webinar
UDI expert John Lorenc of Reed Tech examines post-submission UDI data maintenance and data management responsibilities and strategies.
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.
REMS in SPL Webinar
SPL expert Gary Saner discusses the FDA's new initiative to receive Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling format.
Data Submitted! But the UDI Journey Continues...
September 24 and the Class II UDI deadline compliance date is past. But UDI is not over. For medical device labelers, it will always require maintenance and ongoing work. UDI is the new normal.
4 Reasons to Submit REMS in SPL Now
Some industry members may question whether REMS in SPL is worth the effort, since SPL is not yet mandated for REMS. Here are four great reasons to get start submitting REMS in SPL now.
FDA Drug Establishment Site Registration Webinar
SPL subject matter expert Jon Nolan gives an overview of the FDA's requirements for registering Drug Establishment sites. Learn More: http://www.reedtech.com/products-services/life-sciences/structur
The Anatomy of a National Drug Code (NDC)
An NDC is a 10 digit number that uniquely identifies a drug product by stringing together three separate code segments. A complete NDC is made up of a labeler code, a product code and package code.
Drug Establishment Registration Reporting Requirements and Timelines
Every electronic drug establishment registration must be renewed or updated annually between October 1 and December 31, regardless of whether there have been changes to the data.
UDI Data Submission Case Study: Henry Schein
As the Henry Schein team was faced with collecting...and maintaining all of this data for each product in U.S. distribution, they realized the process would be extremely time consuming.
Time is Up! Class II UDI Deadline Tomorrow
For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.
UDI Q&A with Jay Crowley and Gary Saner
On September 8th, 2016, UDI experts Jay Crowley (USDM) and Gary Saner (Reed Tech) took questions live from industry members working to meeting the September 24 deadline for Class II medical devices.
FDA UDI Class II Extension: Does it apply to your products?