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Dan Henrich

  • 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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  • National Drug Code (NDC) Assignment Guide eBook

    National Drug Code (NDC) Assignment Guide eBook

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  • GS1, GTIN, GDSN--What do they have to do with UDI?

    GS1, GTIN, GDSN--What do they have to do with UDI?

    If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, like “GS1,” “GTIN” and “GDSN.”

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  • UDI Data Security: Why it should be important to you

    UDI Data Security: Why it should be important to you

    Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio.

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  • Data Submitted! But the UDI Journey Continues...

    Data Submitted! But the UDI Journey Continues...

    September 24 and the Class II UDI deadline compliance date is past. But UDI is not over. For medical device labelers, it will always require maintenance and ongoing work. UDI is the new normal.

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  • 4 Reasons to Submit REMS in SPL Now

    4 Reasons to Submit REMS in SPL Now

    Some industry members may question whether REMS in SPL is worth the effort, since SPL is not yet mandated for REMS. Here are four great reasons to get start submitting REMS in SPL now.

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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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  • UDI Data Submission Case Study: Henry Schein

    UDI Data Submission Case Study: Henry Schein

    As the Henry Schein team was faced with collecting...and maintaining all of this data for each product in U.S. distribution, they realized the process would be extremely time consuming.

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  • Time is Up! Class II UDI Deadline Tomorrow

    Time is Up! Class II UDI Deadline Tomorrow

    For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.

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  • FDA now accepting REMS in SPL format

    FDA now accepting REMS in SPL format

    Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient.

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  • Just 25 Business Days Remaining Before the Class II UDI Deadline!

    Just 25 Business Days Remaining Before the Class II UDI Deadline!

    If your company markets Class II devices in the U.S., have you successfully submitted your UDI records to the FDA? If not, are you on the path to full compliance within the next 25 business days?

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  • What's the real cost of UDI compliance?

    What's the real cost of UDI compliance?

    UDI team leaders should ask themselves these important questions about the total costs of their UDI data submission and management plan.

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  • Should you DIY UDI?

    Should you DIY UDI?

    DIY is a growing movement. But for DIY projects, you should always use the right tool for the job and take advice from an expert. Is DIY for UDI the right approach for your organization?

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