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Regulatory Focus™ > News Articles > The Future of FDA’s e-Listing Initiative

The Future of FDA’s e-Listing Initiative

Posted 01 June 2010

The year 2006 marked a major transformation in the way drugs are brought to market and the way package inserts (i.e., labels) are processed. The US Food and Drug Administration (FDA) published final regulations requiring the content of labeling for generic and novel drugs and biologics to be submitted electronically in a format the agency could process, review and archive by machine.1 A new standard called Structured Product Labeling (SPL) was introduced, requiring the content of labeling to be ordered in a certain way and to contain specific information including a table of contents, a highlights section with drug warnings and risks and noting the US drug approval date.2


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