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Zdrowie i gospodarka · 19/03/2007

Draft Guidance for Industry on Indexing Structured Product Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Indexing Structured Product Labeling." This guidance explains that the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drugs. This guidance also makes recommendations to industry on how to request a change to the indexing information in the SPL.

Source: Federal Register — Food and Drug AdministrationOpen original release →