FDA Issues Guidance on Electronic Submission of Lot Reports for BLAs

The Food and Drug Administration March 20 released a final guidance for industry on the electronic submission of lot distribution reports for applicants with approved biologics license applications (BLAs).

A notice announcing the guidance was published in the March 23 Federal Register (80 Fed. Reg. 15,217).

The FDA published a final rule in the June 10, 2014, Federal Register (79 Fed. Reg. 33,072), requiring, among other things, that lot distribution reports be submitted in an electronic format that the agency can process, review and archive.

The guidance is the final version of a draft ...