medwatch reports Posts

4 Nuances to Nothing in eMDR Electronic MedWatch Reports (A Riddle)

4 Nuances to Nothing in eMDR Electronic MedWatch Reports (A Riddle)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Riddle me this: Why is an eMDR not a true electronic equivalent of a Form FDA 3500A MedWatch report?

Do you know the answer? If you don’t — that is, if you didn’t respond, or your mind went blank on this riddle — well, then you’d technically be correct. If this still isn’t making sense, you’ll understand by the end.

You see, aside from the obvious answer that one is a fillable PDF form and the other is an electronic XML file, there also are distinctions regarding the acceptable manner for leaving fields blank when you have “nothing” to answer. (more…)