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Life Sciences

Life Sciences

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...

Reed Tech® Introduces Reed Tech Navigator™ for Medical Devices

  Horsham, Penn. – April 10, 2017 – Reed Technology and Information Services Inc. (Reed Tech), a leader in data analytics and information services for the Life Sciences industry, announces the launch of Reed Tech Navigator™ for Medical Devices. Navigator is a new...

Drug Product Annual Reporting Periods

Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods...

FDA’s Electronic Drug Listing Requirements for Manufacturers

If your company manufactures drug products for distribution in the United States, you probably know that you are required to register your establishment site(s) annually with FDA in Structured Product Labeling (SPL) format. Many manufacturers are unaware, however,...

National Drug Code (NDC) Assignment Guide eBook

One of the topics our team receives frequent questions about is National Drug Codes (NDCs). How are they structured? Where do they come from? What’s the difference between an NDC labeler code, product code and package code? To help industry members understand...