Life Sciences
FDA Drug Listing: When You Need a Manual Override
One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents...
Webinar: FDA Drug Listing Requirements for Manufacturers & Distributors
Join Jon Nolan and Gary Saner of Reed Tech to learn about FDA requirements for electronic Drug Listing and their application to Contract Manufacturing (CMO) and Private Label Distributor (PLD) organizations. WATCH NOW FOR: Electronic Drug Listing Environment History...
Structured Product Monograph: Health Canada Plants its SPL Flag
In 2016, Health Canada announced its intention to adopt a structured format for its drug product monographs. In harmonization with international data standards, Canada selected the HL7 Structured Product Labeling (SPL) authoring standard for its product monograph...
Webinar: EU MDR’s Impact on Labeling: UDI in Europe and Other Changes
Gary Saner of Reed Tech and Mark Cusworth of PRISYM ID discuss the new EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and the impact on labeling, including label formats, IFU information and symbols. WATCH NOW FOR: Label requirements...
The Continuing Evolution of UDI: Highlights from the 2018 UDI Conference (Part 2 of 2)
Please note, this is Part Two of a two-part blog on the 2018 UDI Conference. You can read Part One here. FDA Makes GUDID Changes to Improve Data Quality Throughout the UDI Conference, FDA representatives continued to drive home the message of their 2018 data quality...
UDI Flows Downstream: Highlights from the 2018 UDI Conference (Part 1 of 2)
At the end of April, medical device regulatory professionals, FDA representatives, technology providers and other industry members met together in Baltimore to discuss all things related to Unique Device Identification at the annual UDI Conference. If there was one...
Video: Deeper Market Research with Reed Tech Navigator™ for Medical Devices
Reed Tech Navigator™ for Medical Devices A whole new way to conduct deeper market research with safety and quality data. Learn more at ReedTech.com/Navigator Sign up for a demo of...
Video: Informed Product Development with Reed Tech Navigator™ for Medical Devices
Reed Tech Navigator™ for Medical Devices A whole new way to make data-driven product development decisions. Learn more at ReedTech.com/Navigator Sign up for a demo of...
Video: Effective Post-Market Surveillance with Reed Tech Navigator™ for Medical Devices
Reed Tech Navigator™ for Medical Devices A whole new way to conduct post-market surveillance analysis using device safety and quality data. Learn more at ReedTech.com/Navigator Sign up for a demo of...
Video: Superior Risk Management with Reed Tech Navigator™ for Medical Devices
Reed Tech Navigator™ for Medical Devices A whole new way to make data-driven risk management decisions for your device portfolio. Learn more at ReedTech.com/Navigator Sign up for a demo of...
FDA Changes to Drug Listing Process for Contract-Manufactured Products
The FDA recently introduced two significant changes to its process for drug listing products manufactured by contract manufacturing organizations (CMOs). It is important for CMOs and Private Label Distributors (PLDs) to understand these changes and make sure they...
Webinar: Harmonizing your EU MDR Efforts with FDA UDI
Gary Saner and John Lorenc of Reed Tech discuss UDI requirements in the EU and how device companies can align their EU compliance efforts with existing FDA UDI programs. WATCH NOW FOR: EU MDR / IVDR Overview EU UDI Requirements and Comparison to FDA UDI Global Data...
FDA is Sharpening its Focus on UDI Data Quality
In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID. In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira...
Webinar: FDA Expectations for Biologic Lot Distribution Reporting
Watch our On-Demand WebinarJoin our mailing list to receive the latest news and updates from our team. WATCH NOW Thank You! David Wilson of Reed Tech discusses FDA requirements for Biologic Lot Distribution Reports (LDR) and what industry has learned three years since...
Webinar: NHS eProcurement Requirements in 2018
Gary Saner of Reed Tech discusses of what medical device companies need to do in 2018 to comply with the National Health Service eProcurement requirements and how affected medical device labelers can meet the deadline. WATCH NOW TO LEARN: UK NHS eProcurement...
Business Development Insights from Medical Device Safety and Quality Data
More big data is now available at our fingertips than ever before. Leading companies in every industry are harnessing the power of data analytics to drive informed decisions across their business processes. Medical device manufacturers, in particular, should be making...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices, Advancing the Ability to Manage and Share Device Product Data
Reed Tech, a LexisNexis® company and leading provider of data management and analytics solutions for the life sciences industry, introduces Reed Tech SingleSource for Medical Devices, a data management tool built specifically to meet the needs of medical device...
You Missed the Drug Listing No Change Certification Deadline…Now What?
You may have seen one of our recent posts about the FDA’s new Blanket No Change Certification submission requirement for drug products. If not, you can get a quick rundown of the requirements here. To help track compliance with the new requirements, FDA has added a...
Webinar: FDA’s No Change Certification for Drug Products
In this webinar, you’ll get an overview of the requirements for FDA’s new Blanket No Change Certification submission type for drug product listings. Presenter Jon Nolan will address the following: What’s Changing Requirements and Timelines Questions...
FDA’s New Drug Product Listing Blanket No-Change Certification
As part of the 2016 Final Rule on Electronic Drug Listing, FDA introduced important new changes that affect all human drug product labelers and manufacturers. Beginning in 2017, every existing human drug product listing must be either 1) updated during the course of...
A Joint Solution: Manage & Syndicate Device Product Data with Reed Tech & 1WorldSync
Medical device professionals face an ever-growing list of demands for their product data from downstream users all over the world. Some of these demands are regulatory, such as FDA’s Unique Device Identification (UDI) submission mandate. Others are commercial, such as...
