FDA Guidance Outlines Submissions for Contrast Imaging Indications

The 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. When an imaging drug modification would allow an approved device to be used without change for the new indication, the drugmaker should submit an NDA or BLA supplement, the guidance in Wednesday’s Federal Register says.
Drug Industry Daily