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  • Title: Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2003 Dec 11; 68(238):69009-20. PubMed ID: 14672084.
    Abstract:
    The Food and Drug Administration (FDA) is amending its regulations governing the format in which certain labeling is required to be submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), supplements, and annual reports. The final rule requires that certain labeling content be submitted electronically in a form that FDA can process, review, and archive. Submitting the content of labeling in electronic format will simplify the drug labeling review process and speed up the approval of labeling changes.
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