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  • 1.  Packaging Materials CDER Approved

    Posted 09-Aug-2017 16:42
    Dear Team,

    Can someone please assist me with the subject? We are repackager/relabeler pharmaceutical. We were recently requested to provide such document from our customer.

    Any feedback is much appreciated!

    Thanks,
    Trish

    ------------------------------
    Trisha
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  • 2.  RE: Packaging Materials CDER Approved

    Posted 11-Aug-2017 09:57
    Packaging materials usually hold type-III DMFs.

    You can request DMF Access letter for all packaging components from their suppliers and you can provide that.

    ------------------------------
    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Original Message


  • 3.  RE: Packaging Materials CDER Approved

    Posted 16-Aug-2017 15:31
    Dear Trish,

    I agree with Gauraung.

    But, if you are providing packaging materials that do not currently have Drug Master Files on file with the FDA, you'll have to create the DMFs. We could help create and file these to meet current FDA [and Canadian] expectations.

    Best,
    Phil

    ------------------------------
    Phill Triolo PhD RAC
    President
    Phil Triolo & Associates LC
    Salt Lake City UT
    United States
    philt@philt.com
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    Original Message


  • 4.  RE: Packaging Materials CDER Approved

    This message was posted by a user wishing to remain anonymous
    Posted 17-Aug-2017 11:04
    This message was posted by a user wishing to remain anonymous

    ​The only caviat to the discussion is that Drug Master Files are never approved. They are only reviewed in conjuction with a  drug application (ANDA,BLA,etc) and at that point only referenced.

    If you are going to file a Drug Master file, please be aware of the eCTD format requirment becomes offical in May 2018.
    Original Message


  • 5.  RE: Packaging Materials CDER Approved

    Posted 17-Aug-2017 12:28
    Thank you all for the information!

    DMFs are approved. The manufacturer requested our approved packaging materials as an assurance. 

    Thanks,
    Trish

    ------------------------------
    Trisha
    ------------------------------

    Original Message


  • 6.  RE: Packaging Materials CDER Approved

    Posted 17-Aug-2017 12:53
    ​Hello Trish,

    I believe you are mistaken.  Per FDA guidance "DMFs are neither approved nor disapproved".   Drug Master Files (DMFs)
    Fda remove preview
    Drug Master Files (DMFs)
    There appears to be some confusion regarding when a Type III DMF (packaging material) should be submitted. It is not required that packaging information be submitted to the FDA in a DMF. The responsibility for providing information about packaging components rests foremost with the applicant of an NDA, ANDA or BLA, or the sponsor of an IND.
    View this on Fda >
     

    Although I believe that for your purposes, a Master File may fit your needs.

    ------------------------------
    Matthew Tennen


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    Original Message


  • 7.  RE: Packaging Materials CDER Approved

    Posted 17-Aug-2017 13:16
    There is nothing about a DMF for FDA to approve.  

    FDA has some requirements for format, etc, in order for it to accept the DMF, but that's not approval.  It also has requirements in order for it to accept regulatory submissions, but the fact that it has accepted the for filing doesn't mean it's approved anything.

    If you have what you think is an approval letter in hand for a DMF, you may want to examine the language more closely.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 8.  RE: Packaging Materials CDER Approved

    Posted 17-Aug-2017 13:12
    ​I will also chime in with a reminder that FDA approves finished pharmaceutical, medical device, diagnostic products, It does not approve materials or packaging or components or manufacturing facilities.  Be cautious in your claims.


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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