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FDA Finalizes Guidance on Labeling

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Specifically, the guidance includes detailed descriptions of the data required for the clinical pharmacology section of the labeling for drugs, biologics and generics for new submissions, as well as amendments to a product’s labeling.

FDA first released the draft version of the guidance in 2009 in order to meet the goals established in its 2006 Physicial Labeling Rule (PLR). However, in 2014, FDA released a revised version of the draft guidance in response to calls for the agency to clarify the information that should be included and how to use headings and subheadings in the section.

Source: Regulatory Affairs Professionals Society

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