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Electronic Drug Registration and Listing (eDRL)

  • Why Data Accuracy in Drug Listings is Essential

    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.

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  • Drug Product Annual Reporting Periods

    Drug Product Annual Reporting Periods

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  • GDUFA Self-Identification: What Generic Companies Need to Know35:25

    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.

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  • GDUFA and Self-Identification: What’s changing? (And What’s Not?)

    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.

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  • FDA’s Electronic Drug Listing Requirements for Manufacturers

    FDA’s Electronic Drug Listing Requirements for Manufacturers

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  • National Drug Code (NDC) Assignment Guide eBook

    National Drug Code (NDC) Assignment Guide eBook

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  • FDA Drug Establishment Site Registration Webinar31:30

    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

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  • The Anatomy of a National Drug Code (NDC)

    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.

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  • Drug Establishment Registration Reporting Requirements and Timelines

    Drug Establishment Registration Reporting Requirements and Timelines

    Every electronic drug establishment registration must be renewed or updated annually between October 1 and December 31, regardless of whether there have been changes to the data.

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