Regulatory Open Forum

 View Only

  • 1.  Transfer of BLA Ownership

    Posted 20-Nov-2019 16:02
    Dear Colleagues,

    Does anyone have experience in BLA ownership transfer?  I am interested in how long the FDA takes to re-issue the license to the Buyer under SOPP 8403.

    Thank you!

    David Lucking

    ------------------------------
    David Lucking
    FL
    United States
    ------------------------------


  • 2.  RE: Transfer of BLA Ownership

    Posted 21-Nov-2019 12:31
    I went through this but it was 10 years ago. I recall it was several months for FDA to approve. But in my case the receiving sponsor did not have a US License No. yet (different from the BLA No.) so that may have contributed to the delay.  Also, in this case the BLA was in CDER, not CBER so that may also have caused delay.  Hopefully it's quicker now.​​

    ------------------------------
    Tom
    Senior Director, Regulatory Affairs CMC
    Chicago
    ------------------------------

    Original Message


  • 3.  RE: Transfer of BLA Ownership

    Posted 21-Nov-2019 13:14
    Hi David,
    I was involved when one diagnostic company with a US license number was purchased by another IVD company who also held a US license number, both for CBER BLA approved assays. This was in 1999 but things probably haven't changed much. FDA CBER required the license number of the acquired company be changed to the number of the acquiring company. FDA allowed a transition period of approximately 6 months to change over product labeling with the new license number. It was during this time we received a letter with the new facility license number.  Probably in 2-3 months. I hope this helps.

    ------------------------------
    Christopher Bentsen FRAPS
    retired
    Redmond WA
    United States
    ------------------------------

    Original Message


Related Content