Home » US Guidance Outlines Submissions for Contrast Imaging Indications
US Guidance Outlines Submissions for Contrast Imaging Indications
January 14, 2010
The U.S. Food and Drug Administration (FDA) has issued a final guidance detailing when developers of imaging drugs can add new indications to approved
products without changing associated device labeling and the type of marketing submission they must make to get new indications approved.
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