USFDA has recently issued a draft guidance for industry comments on Electronic Submission of Lot Distribution Records.
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.
For Detailed Copy of the Draft Guidance on Electronic Submission of Lot Distribution Records CLICK HERE
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