Zdrowie i gospodarka · 02/06/2008

Guidance for Industry on Indexing Structured Product Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Indexing Structured Product Labeling." This guidance explains that the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drug and biologic products. This guidance also makes recommendations to industry on how to submit input regarding the indexing information in the SPL.