What constitutes FDA's First in Class designation for New Molecular Entities?
&quot;First-in-class drugs are ones that use a new and unique mechanism of action for treating a medical condition. These products are often referred to as innovative and cited as offering new treatment options for patients.&quot;
Lanthier, M. et al. (2013) &quot;An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.&quot; J.Health Aff. (Millwood) 32:1433-9;
Pharmaceutical Research and Manufacturers of America. 2015b. Innovative Oncology Medicines Have Led to Impressive Gains in Patient Survivorship. Retrieved August 26, 2015. &lt;www.phrma.org/innovative-oncology-medicines-have-led-to-impressive-gains-in-survivorship&gt;.&quot;
From: Lexchin, J. (2016) &quot;How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study&quot; Healthc. Policy 12:65-7.