Do Physicians Understand What Level of Evidence Supports FDA's "Breakthrough" Therapy Designation? | Co-creation in health | Scoop.it
From pharmamkting.blogspot.com - April 12, 2016 4:01 PM

FDA uses a bevy of new drug approval designations that marketers and, in turn, journalists, can use to their advantage. In 2015, for example, 60% of of the 45 drugs approved by the FDA were designated in one or more the following categories: "Fast Track," "Breakthrough," "Priority Review," or "Accelerated Approval."

Perhaps the most advantageous designation as far as marketers are concerned is "Breakthrough". Ten (22%) of drugs approved in 2015 received the "Breakthrough" designation.

What level of evidence does the FDA require in order to label a drug a "Breakthrough" therapy? Take this short survey and then see how physicians answered the question according to a new study published in JAMA.


Via Pharma Guy