Issue Date: March 23, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final
Electronic Submission of Lot Distribution Reports: Guidance for Industry
This guidance provides you, licensed manufacturers of products distributed under an approved biologics license application (BLA) (henceforth referred to as applicants), with recommendations on how to submit lot distribution reports (LDRs) for biological products in an electronic format that FDA can process, review, and archive.
Download the Guidance Document
