Biologic Lot Distribution Data must be submitted in SPL XML format within eCTD submissions
On June 10, 2014, the FDA issued a new rule which amended the requirements for biological LDRs. Under this new rule, applicants are required to submit LDRs to the FDA in an electronic format that the agency can process, review, and archive. This reporting requirement is effective as of yesterday, June 10, 2015.
Every six months, applicants must submit to the appropriate center (CBER or CDER), LDRs containing certain specified information about the quantity of the product distributed under their BLAs (including to distributors).
The lot distribution report must be submitted to the FDA in eCTD Module 3, section 3.2.R Regional Information.
