1. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes;Kesselheim;Clin Pharmacol Ther,2015
2. US Food and Drug Administration. Center for Drug Evaluation and Research. (2014, April 25). FDA Drug Approval Process Infographic. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm295473.htm. Accessed March 19, 2015.
3. Administrative actions, 21 C.F.R. § 312.47 (2014).
4. Early consultation, 21 C.F.R. § 312.82. (2014).
5. US Food and Drug Administration. (2011, September 1). Proposed PDUFA V Reauthorization Performance Goals and Procedures; Fiscal Years 2013 through 2017. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Accessed December 4, 2014.