FDA / Industry Updates

  • You Missed the Drug Listing No Change Certification Deadline…Now What?

    You Missed the Drug Listing No Change Certification Deadline…Now What?

    If a drug product listing was not updated or certified in 2017 as containing no changes to the information on file, it has now been flagged in the NDC Directory as an uncertified product.

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  • Webinar: FDA's No Change Certification for Drug Products

    Webinar: FDA's No Change Certification for Drug Products

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  • 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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  • 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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  • NHS eProcurement Q&A19:55

    NHS eProcurement Q&A

    Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to MedDevice@ReedTech.com

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  • NHS eProcurement Requirements, Timelines and Strategies50:51

    NHS eProcurement Requirements, Timelines and Strategies

    Join Gary Saner and John Lorenc of Reed Tech for a discussion of the UK National Health Service's eProcurement requirements and how affected medical device labelers can comply.

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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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  • FDA Insight: UDI Data Quality

    FDA Insight: UDI Data Quality

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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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  • UDI Post-GUDID Publishing Webinar1:00:16

    UDI Post-GUDID Publishing Webinar

    UDI expert John Lorenc of Reed Tech examines post-submission UDI data maintenance and data management responsibilities and strategies.

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  • REMS in SPL Webinar1:03:44

    REMS in SPL Webinar

    SPL expert Gary Saner discusses the FDA's new initiative to receive Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling format.

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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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  • 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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  • 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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  • 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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  • UDI Q&A with Jay Crowley and Gary Saner1:01:48

    UDI Q&A with Jay Crowley and Gary Saner

    On September 8th, 2016, UDI experts Jay Crowley (USDM) and Gary Saner (Reed Tech) took questions live from industry members working to meeting the September 24 deadline for Class II medical devices.

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  • FDA UDI Class II Extension: Does it apply to your products?

    FDA UDI Class II Extension: Does it apply to your products?

    This week, the FDA issued a letter extending the UDI labeling and data submission compliance date to 2018 for certain categories of Class II devices.

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