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Drug & Biologic Product Submissions

Drug & Biologic Product Submissions

National Drug Code (NDC) Assignment Guide

Drug Establishment Registration Reporting Requirements

Reed Tech SPL Solutions

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: 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: 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: 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...

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...

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...

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...

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,...