title: Recent drug approvals from the US FDA and EMEA: what the future holds.
abstract: The decreased productivity of the pharmaceutical industry in terms of new medical entities approved by the US FDA and the European Medicines Agency (EMEA) on a yearly basis has long been debated. This review will analyze overall new drug applications (NDAs) approved by both the FDA and EMEA in 2007, with the aim of finding trends (also looking at the past) that can be used to predict what the future may be. After a general introduction to the regulatory terminology, NDA approvals in 2007 are divided into categories (new applications of old medicines, metabolites, enantiomers and prodrugs, biological products, natural products and small organic molecule new molecular entities) and discussed. General aspects of the NDA approvals, such as historical trends, the length of the drug-discovery process, geography, differences among therapeutic areas, and the relative role of biotech and pharma industries are also outlined. From this analysis, a perspective is gained on some aspects that will probably influence future drug approvals. The conclusion is that 2007 may represent an inflexion point, in terms of quality if not quantity of new approvals, and that the future may be brighter than previously forecast.
authors.affiliation: Department of Medicinal Chemistry, Experimental Therapeutics Programme, Centro Nacional de Investigaciones Oncologicas (CNIO), C/ Melchor Fernandez Almagro, 3, 20029 Madrid, Spain. paolo.pevarello@newron.com
authors.forename: Paolo
authors.initials: P
authors.lastname: Pevarello
mesh_terms: D001688:Biological Products / Q000600:supply & distribution; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000191:economics; D004345:Drug Industry / Q000191:economics; D016568:Drugs, Generic / Q000600:supply & distribution; D005060:Europe; D006801:Humans; D054852:Small Molecule Libraries / Q000600:supply & distribution; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D016568:Drugs, Generic; D054852:Small Molecule Libraries