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Life Sciences

Life Sciences

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...

Webinar: UDI and the EU MDR: What You Need to Know

In this webinar, you’ll get an overview of the requirements for the upcoming Unique Device Identification (UDI) initiative in the EU from Reed Tech and PRISYM ID team members. Presenters Chris Lentz, Gary Saner and Phil Dray will address the following: EU MDR /...

Webinar: FDA Annual Reporting Period for Drug Products

In this webinar, you’ll get an overview of the FDA’s requirements for submissions during the annual reporting period to the electronic Drug Registration and Listing (eDRL) system. That includes drug product site Establishment Registrations and a brand new...

NHS eProcurement Q&A

Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to...

FDA Changes the Process for Drug Product Listings with No Updates

Yes, you read that correctly. 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. You may have heard that, as part of the eDRL Final Rule...

UK NHS eProcurement: The What, Who, Why and When

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite...

Structured Product Labeling, Eh? Health Canada’s SPL Pilot

Did you know that Health Canada, the department of the Canadian government that regulates drug products, is engaged in a pilot program to introduce electronic submissions of drug product information in Structured Product Labeling (SPL) format? Officially named the...

FDA Insight: UDI Data Quality

On June 7 and 8, the medical device industry joined the FDA for the ninth Annual UDI Conference. With a recent UDI extension for Class I device labelers, industry members had an increased interest in FDA’s commentary on the state of the UDI mandate. During the two-day...

Why Data Accuracy in Drug Listings is Essential

Every product on the market in the U.S. containing an active drug ingredient is required to be electronically drug listed with the FDA and assigned a National Drug Code (NDC). During this process, drug labelers submit complete electronic copies of the Content of...

Zoom In: A Closer Look at Device Safety Data

In our last post, we discussed how the media, Congress and the FDA is paying increased attention in recent years to medical device safety. We highlighted the cost to the device industry of FDA enforcement actions (Reed Tech estimates $4 billion per year). We also...

In the Spotlight: Medical Device Safety and Quality Events

If you regularly watch TV news, visit online news sites or listen to news radio, you have probably seen a lot of medical devices in the mainstream media in recent years. Unfortunately, much of this attention has been negative, centered on adverse events resulting in...

UDI Update: New FDA GUDID Technical Documents Released

Did you know that FDA recently updated some technical documents related to GUDID submissions? On March 31, the agency sent an email to its list of GUDID email subscribers with links to an updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation...