CDER New Drug Review: 2013 Update http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM378227.pdf I found this chart interesting images.investorshub.advfn.com/images/uploads/2013/12/12/ybxrlc.JPG Thanks to @AlecGaffney from the following article FDA Provides Update on Breakthrough Product Designation Program, Showing Industry Interest http://www.raps.org/focus-online/news/news-article-view/article/4409/fda-provides-update-on-breakthrough-product-designation-program-showing-industr.aspx