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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

Stay Current with FDA Blanket No-Change Certification

Stay Current with FDA Blanket No-Change Certification

The fourth quarter of 2020 is fast approaching along with the Blanket No-Change deadline of December 31st. For drug manufacturers, action needs to be taken to keep product listings active before the calendar turns to 2021. What drug listings have to be updated? Every...

The Anatomy of a National Drug Code (NDC)

The Anatomy of a National Drug Code (NDC)

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) 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 and universally identifies a...

Electronic Drug Listing and Registration Guides

Electronic Drug Listing and Registration Guides

To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide with step-by-step instructions and ways to simplify and expedite the process. Download your free guide here. The eDRL How-to Guide answers questions...

Expedited Assistance for Regulatory Compliance Related to COVID-19

Expedited Assistance for Regulatory Compliance Related to COVID-19

Many organizations are stepping up to innovate and transform their operations to implement goods and services needed in the battle against COVID-19. Reed Tech stands ready to help and is making mitigation of COVID-19 a priority. We remain fully operational to assist...

The National Drug Code (NDC) 10 & 11 Digit Format

The National Drug Code (NDC) 10 & 11 Digit Format

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) 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 and universally identifies a...

Drug Establishment Registration: What You Need to Know

Drug Establishment Registration: What You Need to Know

Registration Deadline December 31, 2020                                      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...

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