NMEs and NCEs by year, 1963–2003. FDA: United States Food and Drug Administration. Tufts: stands for Tufts Centre for Study of Drug Development which is a pharmaceutical industry supported research centre located at Tufts University. NME: New Molecular Entity. A new molecular entity is defined by FDA as a new product containing as its active ingredient a chemical substance marketed for the first time in the United States ([54], quoted in [55]). NCE: New Chemical Entity. The Tufts Centre for Study of Drug Development has defined an alternative to the NME—the New Chemical Entity. An NCE is defined to be any new molecular compound (excluding diagnostic agents, vaccines, and other biologic compounds) not previously approved for human use by Centre for Drug Evaluation and Research (CDER) which is a division of FDA. New salts, esters, and dosage forms of previously approved compounds are also excluded (Tufts CSDD Glossary, 2004, quoted in [55]). In this figure the difference between NME approval volumes and NCE volumes is accounted for by a small number of molecules which Tufts CSDD considers to be diagnostic (and therefore not an NCE) but are counted as NMEs by the FDA (Di Masi interview, 2004, quoted in [55]). Source: FDA, Parexel Pharmaceutical Industry R & D Source Book, 2004/2005, as shown in Graham [55].