Daniel Henrich

  • FDA’s New Drug Product Listing Blanket No-Change Certification

    FDA’s New Drug Product Listing Blanket No-Change Certification

    Now, in addition to submitting updates to any product listings as they occur, drug product companies must submit a Blanket No Change Certification during the annual reregistration period.

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  • A Joint Solution: Manage & Syndicate Device Product Data with Reed Tech & 1WorldSync

    A Joint Solution: Manage & Syndicate Device Product Data with Reed Tech & 1WorldSync

    Manage & Syndicate Medical Device Product Data with Reed Tech & 1WorldSync

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  • Webinar: UDI and the EU MDR: What You Need to Know

    Webinar: UDI and the EU MDR: What You Need to Know

    Reed Tech Life Sciences and PRISYM ID team members discuss Unique Device Identification in the EU.

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  • Webinar: FDA Annual Reporting Period for Drug Products

    Webinar: FDA Annual Reporting Period for Drug Products

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  • Reed Tech Navigator™ for Medical Devices Recognized with a 2017 Connectiv Innovation Award

    Reed Tech Navigator™ for Medical Devices Recognized with a 2017 Connectiv Innovation Award

    The Connectiv Innovation Awards recognize ground-breaking innovations bringing solutions to challenges seen within the B2B space.

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  • FDA Changes the Process for Drug Product Listings with No Updates

    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.

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  • UK NHS eProcurement: The What, Who, Why and When

    UK NHS eProcurement: The What, Who, Why and When

    eProcurement is a requirement for any organization doing business with an NHS care provider. For most device companies operating in the U.K., NHS is by far the largest customer in that market.

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  • Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)

    Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)

    FDA’s Class I extension is about ensuring GUDID data quality and submission accuracy, not about giving industry time to work on other projects.

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  • Structured Product Labeling, Eh? Health Canada’s SPL Pilot

    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.

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  • 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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  • Despite Extension, 2017 UDI Deadline Still Holds for Certain Contact Lenses

    Despite Extension, 2017 UDI Deadline Still Holds for Certain Contact Lenses

    FDA delayed the UDI deadline for soft contact lenses to a future undetermined date but the September 24, 2017 deadline for rigid, gas-permeable contact lenses remains unchanged.

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  • Reed Tech Introduces GDSN Capabilities in Collaboration with 1WorldSync™

    Reed Tech Introduces GDSN Capabilities in Collaboration with 1WorldSync™

    The Reed Tech Life Sciences Team is pleased to announce that we are now offering a full-service solution to allow medical device organizations to share product data through the GDSN.

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  • Zoom In: A Closer Look at Device Safety Data

    Zoom In: A Closer Look at Device Safety Data

    There is a staggering amount of medical device safety data available from U.S. government sources. Where can we find it? What can it tell us?

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  • In the Spotlight: Medical Device Safety and Quality Events

    In the Spotlight: Medical Device Safety and Quality Events

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  • UDI Update: New FDA GUDID Technical Documents Released

    UDI Update: New FDA GUDID Technical Documents Released

    FDA sent an email to its list of UDI GUDID email subscribers with updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation Files.

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  • Reed Tech® Introduces Reed Tech Navigator™ for Medical Devices

    Reed Tech® Introduces Reed Tech Navigator™ for Medical Devices

    Navigator is a new analytics and research solution that makes it easy to analyze and compare the safety and quality of tens of thousands of medical device products.

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  • Drug Product Annual Reporting Periods

    Drug Product Annual Reporting Periods

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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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  • Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync

    Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync

    This agreement will allow Reed Tech customers to access the Global Data Synchronization Network (GDSN) and provide 1WorldSync customers with expanded options for managing their regulatory data.

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  • FDA’s Electronic Drug Listing Requirements for Manufacturers

    FDA’s Electronic Drug Listing Requirements for Manufacturers

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