Recent Changes

Tuesday, February 7

  1. page Drug Listing edited ... Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of 2016: August 10 and …
    ...
    Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of 2016: August 10 and 24, September 7 and 21, October 5 and 19, November 9 and 23, December 7 and 21
    2017 Meeting minutes
    ...
    Meeting Minutes - Draft pending answers/clarifications from EDRLS
    {20170111 SPL
    ...
    - final rule and MEI- draft.pdf}rule_MEI- w FDA responses.pdf}
    2016 Meeting minutes
    ...
    Meeting Minutes - Draft pending responses from FDA's Paul Loebach and Lelya Rahjou-Esfandiary to the additional questions. In the meantime send new questions to Pat Cowall-Hanover (Lilly)
    {20161019 SPL ERDL minutes-FINAL.pdf}
    {20161019 Leyla Final Rule SPL_WGPresentation.pptx}
    (view changes)
    4:10 pm

Thursday, January 26

  1. page Drug Listing edited ... Objective: Address questions and concerns regarding SPL that affect the pharma industry.Co-Lea…
    ...
    Objective: Address questions and concerns regarding SPL that affect the pharma industry.Co-Leaders: Pat Cowall-Hanover (Lilly), Mary Beth Wilusz (Merck) and Herbert O'Brien (Bayer)
    Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of 2016: August 10 and 24, September 7 and 21, October 5 and 19, November 9 and 23, December 7 and 21
    2017 Meeting minutes
    January 17, 2017 Meeting Minutes - Draft pending answers/clarifications from EDRLS
    {20170111 SPL ERDL minutes - final rule and MEI- draft.pdf}

    2016 Meeting minutes
    October 19, 2016 Meeting Minutes - Draft pending responses from FDA's Paul Loebach and Lelya Rahjou-Esfandiary to the additional questions. In the meantime send new questions to Pat Cowall-Hanover (Lilly)
    (view changes)
    11:27 am
  2. page Drug Listing edited ... 2016 Meeting minutes October 19, 2016 Meeting Minutes - Draft pending responses from FDA's Pa…
    ...
    2016 Meeting minutes
    October 19, 2016 Meeting Minutes - Draft pending responses from FDA's Paul Loebach and Lelya Rahjou-Esfandiary to the additional questions. In the meantime send new questions to Pat Cowall-Hanover (Lilly)
    ...
    SPL ERDL minutes-DRAFT.pdf}minutes-FINAL.pdf}
    {20161019 Leyla Final Rule SPL_WGPresentation.pptx}
    {20161019 SPLJamboreeSlidesLoebach.pptx}
    (view changes)
    11:17 am

Tuesday, January 24

  1. msg Submissions on Behalf of Other Cmpanies message posted Submissions on Behalf of Other Cmpanies We register labels for our other clients and I put all their NDC numbers into the Pragmatic applica…
    Submissions on Behalf of Other Cmpanies
    We register labels for our other clients and I put all their NDC numbers into the Pragmatic application as directed & I was approved. It still wont allow me to submit files, the error is "We're sorry, your submission could not be sent because we could not find a match between the contact person, your electronic signature, the company and its NDC codes or DUNS numbers."

    Please help
    1:20 pm
  2. msg Strength Numerator Error but is present on current label message posted Strength Numerator Error but is present on current label Ive been tasked with updating some of our client's labels without knowing exactly how but Im down t…
    Strength Numerator Error but is present on current label
    Ive been tasked with updating some of our client's labels without knowing exactly how but Im down to 3 errors with the most frustrating one being "Strength numerator must be based on mass not volume". The original SPL file has volume listed on it (Strength: 3.785L in 3.785L) but it is kicking it out to me as an error.

    Please help
    1:16 pm

Saturday, January 21

  1. page Vendors edited ... RxTechnologist [outsourcing services] Salamandra[conversion and outsourcing services] SPLGe…
    ...
    RxTechnologist [outsourcing services]
    Salamandra[conversion and outsourcing services]
    SPLGenie[off-the-shelf tool]
    Stat Pharma[outsourcing services]
    SubmissionsPortal [customized products or services, external partner]
    (view changes)
    5:13 pm

Wednesday, January 4

  1. msg TypeID question message posted TypeID question I am looking to identify that s section contains information that needs to be graphically identifie…
    TypeID question
    I am looking to identify that s section contains information that needs to be graphically identified (relates to a Health Canada NOCC), I was thinking of using the typeID element to define that the section has a notice and the extension attribute to identify the type of notice, but I am wondering if there is a better way to do this?

    Suggestions or pointers are welcome.
    12:23 pm

More