Recent Changes

Tuesday, July 25

  1. msg Submission of SPL for non commercial products message posted Submission of SPL for non commercial products Hi, Is it necessary to submit SPL for the products which have a RLD update but we don't intend …
    Submission of SPL for non commercial products
    Hi,

    Is it necessary to submit SPL for the products which have a RLD update but we don't intend to market the same product?

    Also, the same product undergone ownership transfer and they kept marketing end date and as the product is transferred to us, we are submitting RLD update but we don't intend to commercialise the product in near future. so do we need to submit SPL with our submission?
    9:47 pm

Tuesday, July 11

  1. msg REMS requirment message posted REMS requirment can anybody help me to know the REMS guidance and about the implementation date? Also if REMS guid…
    REMS requirment
    can anybody help me to know the REMS guidance and about the implementation date?
    Also if REMS guidance is available kindly provide the details
    10:06 pm
  2. msg Scoring error code message posted Scoring error code OK Guys and gals I am new to the game. I come form a electronics field and now in the medical arena…
    Scoring error code
    OK Guys and gals I am new to the game. I come form a electronics field and now in the medical arena.
    I submitted a NDC that was accepted. I needed to create a new NDC for the same medication for a different package quantity so I click on the new version tab. I wanted to have the same information that was accepted. I just change the packaging information and added my the label showing the new NDC. I received back an error If the NDC product/item code was previously submitted, then the product characteristic of scoring must be the same as in the most recent submission for this NDC product/item code." How can this be I didn't change this.
    10:30 am

Thursday, June 29

  1. msg Tablet imprint update error message posted Tablet imprint update error You are welcome. Good luck.
    Tablet imprint update error
    You are welcome. Good luck.
    9:09 am
  2. msg Tablet imprint update error message posted Tablet imprint update error yes, I been trying to reach them from last 20 days no reply. emailed to edrls@fda.hhs.gov group…
    Tablet imprint update error
    yes, I been trying to reach them from last 20 days no reply. emailed to edrls@fda.hhs.gov group as well, they have replied saying I have to contact 'SPL@fda.hhs.gov'.
    Thanx a lot for your reply.
    8:37 am
  3. msg Tablet imprint update error message posted Tablet imprint update error Strictly speaking yes, but you may want to ask FDA's Electronic Drug Registration and Listing Syste…
    Tablet imprint update error
    Strictly speaking yes, but you may want to ask FDA's Electronic Drug Registration and Listing System group if they would allow the imprint change without requiring a product code change. Their email address is edrls@fda.hhs.gov.

    If they do allow it you will still get the automatic validation error but then you can request a manual override, including the documentation of the waiver from EDRLS. I assume FDA will grant the override.
    8:30 am
  4. msg Tablet imprint update error message posted Tablet imprint update error thank you. working on label with new NDC #. just curious, what if it was a typo error and have to …
    Tablet imprint update error
    thank you. working on label with new NDC #.
    just curious, what if it was a typo error and have to correct the typo error of imprint after few years. it would be the same process?
    7:22 am

Sunday, June 25

  1. msg Tablet imprint update error message posted Tablet imprint update error No, NDC # can never be reused for a different product or package; old rule required allowed a chang…
    Tablet imprint update error
    No, NDC # can never be reused for a different product or package; old rule required allowed a change after 5 years, new rule says never.
    12:39 pm
  2. msg SPL concerns message posted SPL concerns Drug listing (submissions to OC) should be done only after approval. My recommendation is to use a …
    SPL concerns
    Drug listing (submissions to OC) should be done only after approval. My recommendation is to use a start marketing far in the future (say 2037 if you expect to start commercial distribution more than 2 weeks later, to cover yourself if the distribution is delayed. A listing within two weeks of distribution should have the actual start marketing date. This recommendation is made because the arrival of the start marketing date automatically results in the listing appearing on the DailyMed and in the National Drug Code directory; the date in the NDC Directory entry is used to validate reimbursement requests, requests before the date will be rejected.

    The listing should have only the commercialized packages to avoid confusion. If the non-commericalized count is included prescribers and/or consumers may think it is available and those requesting reimbursement may enter the NDC code for that count and get reimbursed for it.

    SPLs submitted as part of the approval process (to the appropriate review division are not publicly available, the DailyMed is supposed to reflect only drug listings for approved commericalized products.

    Howard
    11:57 am

Thursday, June 22

  1. msg SPL concerns message posted SPL concerns can you please look into the following issues: 1) What is the right practice to place marketing …
    SPL concerns
    can you please look into the following issues:

    1) What is the right practice to place marketing start date in SPL ? I have a product in which the marketing would be starting in next 2 months but we have got the approval of the product. Now while drug listing what date shall i put? Can i place a date in future but if i do so it won't be reflected in daily med. Can u please suggest the way forward?
    2) Also, is daily med only used to drug list commercial products because we drug list products after approval as well..where do they reflect then?
    3)Lastly, i have a product in which there are few counts that are being marketed and others are not commercialised. While drug listing, shall i drug list all the counts which are not being commercialised but approved along with the commercial ones?
    Your response would be of great help!
    Thanks
    8:16 pm

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