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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

FDA Changes the Process for Drug Product Listings with No Updates

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

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

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

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

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

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

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

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

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)

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...

Drug Establishment Registration Reporting Requirements and Timelines

Drug Establishment Registration Reporting Requirements and Timelines

Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import into the United States. These include sites engaging in the manufacture of human health prescription drug...

FDA now accepting REMS in SPL format

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...

FDA UDI Enforcement

FDA UDI Enforcement

How will the FDA enforce the requirements of the UDI Final Rule? This video details what the FDA has said so far and what we can expect for UDI policing based on prior agency enforcement...

Electronic Lot Distribution Reports Are More Complex Than You Think

Electronic Lot Distribution Reports Are More Complex Than You Think

New FDA regulations for submitting electronic Lot Distribution Reports (LDRs) went into effect June 10, 2015. They apply to all companies that market products in the U.S. under a Biologics License Application (BLA). Some companies must submit their first reports in...

3 Options for Managing Biologic Lot Distribution Reports (LDR)

3 Options for Managing Biologic Lot Distribution Reports (LDR)

It is not new that the FDA requires the submission of Lot Distribution Reports (LDRs) for all products marketed in the U.S. under a Biologics License Application (BLA). However, it is important for BLA holders to know that a new FDA LDR submission format will soon be...

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