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Home » FDA Draft Guidance Offers Recommendations to Biologics Makers on Submitting Electronic LDRs
FDA Draft Guidance Offers Recommendations to Biologics Makers on Submitting Electronic LDRs
Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions.