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Life Sciences

Life Sciences

Don’t Forget—Medical Device Data Submission Deadlines in 2018

Beginning in September of 2014, medical device manufacturers have faced a series of data submission and maintenance requirements from the FDA as part of its Unique Device Identification (UDI) initiative. The agency phased the compliance deadlines by device class,...

Reed Tech® Introduces Reed Tech Navigator™ for Drug Labels

Horsham, Penn. – July 9, 2018 – Reed Technology and Information Services Inc. (Reed Tech), a provider of high-quality data management and analytics solutions for the life sciences industry, announces the launch of Reed Tech Navigator™ for Drug Labels. Navigator for...

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...

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: 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...

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...