Recent Changes

Today

  1. msg Drug listing problem message posted Drug listing problem I submitted a drug listing with one NDC code and it was accepted and then create a version 2 so tha…
    Drug listing problem
    I submitted a drug listing with one NDC code and it was accepted and then create a version 2 so that I could submit the samples for registration. The only thing that I did was add a new product no other changes and it keeps coming back regarding the scoring needs to be the same as the original? does any one know how to correct this issue?
    5:51 am

Wednesday, November 15

  1. msg SPL entries, product list certification message posted SPL entries, product list certification Most of our product listings were made years and years ago by my predecessor- I assume in SPL forma…
    SPL entries, product list certification
    Most of our product listings were made years and years ago by my predecessor- I assume in SPL format. So currently, the only products showing in CDER direct are a few from the last year or so. How do I review the SPL listings, where can I see a list? I need to do this in order to certify our product list. Do they all need to be re-entered into CDER direct in order to make changes?
    Thanks
    9:51 am

Tuesday, November 14

  1. msg Acknowledgments message posted Acknowledgments Hello all I have sent few submissions yesterday and none of them received the final acknowledgme…
    Acknowledgments
    Hello all

    I have sent few submissions yesterday and none of them received the final acknowledgment.
    receipt and acknowledgment are received. is it a new change in the redesigned webtrader accounts?
    or am I missing something here?
    appreciate your help

    thanx
    nimms
    6:14 am

Tuesday, November 7

  1. msg Establishment Registration message posted Establishment Registration Hello, If an establishment located in the United States who makes API/Drug products for export on…
    Establishment Registration
    Hello,
    If an establishment located in the United States who makes API/Drug products for export only, does this establishment needs to be registered with the FDA? They do not produce anything that is sold in the US.
    7:21 am

Tuesday, October 24

  1. page home edited {http://spl-work-group.wikispaces.com/i/c.gif} Thank You! ... Laboratory, Inc., virtify, Reed …
    {http://spl-work-group.wikispaces.com/i/c.gif} Thank You!
    ...
    Laboratory, Inc., virtify, Reed Technology, and First DataBank haveReed Technology have enabled us
    Any mention of a vendor on this site does not constitute an endorsement.
    Important Note: Please join wikispaces (it's free!) so that you can participate in discussions.
    (view changes)
    2:08 pm

Monday, October 23

  1. page Vendors edited ... Pilgrim Software[configurable or customizable products] RA-IT Associates Reed Technology an…
    ...
    Pilgrim Software[configurable or customizable products]
    RA-IT Associates
    Reed Technology and Information Services, Inc.[conversionTech[conversion and outsourcing
    Reg-e-Stration[conversion and outsourcing services, external partner]
    Registrar Corp.[conversion and outsourcing services, external partner]
    (view changes)
    10:49 am

Monday, October 2

  1. page home edited ... Drugs @ FDA / Pragmatics Validator [if validator is down, send an e-mail to spl@pragmaticdata.…
    ...
    Drugs @ FDA / Pragmatics Validator [if validator is down, send an e-mail to spl@pragmaticdata.com]
    News from the SPL Cybersphere
    [02-Oct 2017] Slides from and links to Links to 2017 NLM DailyMed Jamboree Materials
    Below are links to selected slides from the 2017 NLM DailyMed Jamboree, our thanks to Gary Saner for providing them:
    Overview of hot FDA ERDL topics {20170919 NLM DM Jamboree - ERDL Updates - FDA-Rahjou.pdf}
    Details of the new, annual Blanket No Changes Certification Of Product Listing requirement {20170919 NLM DM Jamboree - SPL-CERT - FDA-Loebach.pdf}
    FDA suffix naming guidelines for biologics and biosimilars {20170919 NLM DM Jamboree - Biologic Names+SPL-Index - FDA-Taylor+Smith.pdf}
    FDA suffix naming guidelines for biologics and biosimilars {20170919 NLM DM Jamboree - UDI - FDA-TReed.pdf}
    Below are links to other materials from the Jamboree, available online:
    Agenda
    All presentations as PDF file
    Full day video

    [19-Jun 2017] Link to 2016 Establishment Registration webinar highlighting changes with the 2016 amendments
    Katharine Detweiler from Teva provided the link below to a very informative CDER webinar on Establishment Registration, given in September 2016. It is a good refresher for those already familiar with establishment registrations and can help answer many questions. The webinar highlights changes that occurred with the 2016 amendments to the drug listing requirements and is titled CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Establishment Registration and Listing for Human Drugs.
    (view changes)
    10:37 am

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