This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

Drug & Biologic Product Submissions

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

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...

FDA Drug Listing: When You Need a Manual Override

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

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...

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...

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...

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...

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close