Enhanced Readability of FDA Indication Statements – Not Yet, Maybe
The FDA issued new draft guidance last Friday along with a press release. Did you notice it?
No, not the one about biosimilars or off-label HEOR discussions. This guidance has the following title: ‘Indications and Usage Section of Labeling for Human Prescription Drug and biological Products – Content and Format.’ 
It is a mouthful, right?
The intent is to provide more concise and explicit descriptions of the conditions and populations for a specific drug indication. I had visions of infographic style labeling with clear and large icons to make scanning the document more accessible for clinicians (and the occasional patient that reads them). Nope. That is not where this is going.