The US Food and Drug Administration has issued guidance explaining how and why manufacturers of biological products should submit their lot distribution reports (LDRs) electronically rather than as paper submissions1.
The guidance, which follows proposals to make electronic reporting of LDRs mandatory2, explains that electronic submissions would eliminate the time and costs associated with submitting paper reports (for industry) and with converting data from paper reports into electronic format for review and analysis (for the FDA)...
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