Enhanced Readability of FDA Indication Statements – Not Yet, Maybe

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The FDA issued new draft guidance last Friday along with a press release.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.’ [1]

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.

The Weakest Link: Failing to Link New Information to Existing Knowledge During Learning

The Weakest Link: Failing to Link New Information to Existing Knowledge During Learning

Completion of training presumes that the learner has acquired the correct information and that it’s now stored in his or her memory. And for highly competitive and skilled teams, that’s usually true.  Following a training, managers often assume that the requisite knowledge has been learned and will be applied appropriately.  However, there are exceptions. There are many potential underlying causes that might prevent an MSL from discussing newly learned information. In this instance, we are going to blame it on failure to use prior knowledge during a learning experience. We will explore other potential causes in separate blogs.