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FDA Changes the Process for Drug Product Listings with No Updates
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.
Structured Product Labeling, Eh? Health Canada’s SPL Pilot
Health Canada is working with volunteer manufacturers and sponsors, as well as technology vendors, to test the application of the HL7 SPL standard to the content of drug product monographs.
Why Data Accuracy in Drug Listings is Essential
This month, FDA issued a warning letter to an OTC drug labeler for failing to provide complete and accurate information in the metadata sections of two drug listing files.
Drug Product Annual Reporting Periods
GDUFA Self-Identification: What Generic Companies Need to Know
Reed Tech subject matter expert Jon Nolan talks GDUFA and Self-Identification during a webinar March 8, 2017.
GDUFA and Self-Identification: What’s changing? (And What’s Not?)
GDUFA requires sites engaged in certain generic drug activities to self-identify annually prior to paying a user fee set by the agency.
FDA’s Electronic Drug Listing Requirements for Manufacturers
National Drug Code (NDC) Assignment Guide eBook
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: http://www.reedtech.com/products-services/life-sciences/structur
The Anatomy 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 NDC is made up of a labeler code, a product code and package code.
Drug Establishment Registration Reporting Requirements and Timelines