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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

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,...

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...

REMS in SPL Webinar

SPL expert Gary Saner discusses the FDA’s new initiative to receive Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling...

4 Reasons to Submit REMS in SPL Now

As you may know, FDA recently began accepting Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling (SPL) format. Although the FDA’s targeted date for acceptance was delayed slightly from September 2, the agency told us that it is...

FDA Drug Establishment Site Registration Webinar

SPL subject matter expert Jon Nolan gives an overview of the FDA’s requirements for registering Drug Establishment sites. Learn More: https://www.reedtech.com/products-services/life-sciences/structured-product-labeling-management Questions? Contact...

The Anatomy of a National Drug Code (NDC)

Part of the FDA’s requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely identifies a drug product by stringing together three separate code segments. A complete...

FDA now accepting REMS in SPL format

Beginning today, September 2, 2016, the FDA is accepting REMS (Risk Evaluation and Mitigation Strategy) submissions in Structured Product Labeling (SPL) format. SPL is an XML document markup standard approved by Health Level 7 and previously adopted by the FDA for...