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We are following FDA "SOPP 8403: Issuance, Reissuance, and Voluntary Revocation of Biological Product Licenses Version: 6 Effective Date: February 27, 2023" to transfer a BLA from a different sponsor. The SOPP states that two regulatory letters will be sent, one to each applicant, after CBER is notified of the transfer.
Does anyone have experience with how long it takes to receive that letter from CBER? There is no timing provided in the procedure.
Thank you in advance for your help.