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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

Drug Establishment Registration Reporting Requirements and Timelines

Drug Establishment Registration Reporting Requirements and Timelines

Registration Deadline December 31, 2019                                      What are Drug Establishment sites? Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import...

Shedding Light on Possible New FDA Sunscreen Regulations

Shedding Light on Possible New FDA Sunscreen Regulations

With Memorial Day Weekend marking the unofficial start of summer, millions of Americans are now enjoying warmer weather and more time outdoors. As consumers restock their beach bags and picnic baskets, the Food & Drug Administration continues to take a closer look...

CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.

CBD Isn’t a Drug. Or Is It? New Regs May Be on the Way.

Author: Carla Long, Account Executive, Life Sciences Congressional passage of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) established a new category of cannabis as “hemp”—that is, cannabis and cannabis derivatives with extremely low concentrations (no...

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 for...

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...

Webinar: FDA Expectations for Biologic Lot Distribution Reporting

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

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

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

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...

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