title: Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan.
abstract: In a study reported herein, the marketing approval dates of 214 drugs newly introduced into the world market from January 1990 through December 1994 were compared in 4 countries. The analysis reveals that the United States and the United Kingdom have similar patterns of drug availability, although the United States has a number of therapies with significant public health benefits that are not yet available in the United Kingdom. The findings also show that the United States outpaces both Germany and Japan in approving important new drugs. Various strategies adopted by the Food and Drug Administration to expedite its pharmaceutical review process, including the use of industry user fees, are described.
authors.affiliation: Office of the Commissioner, Food and Drug Administration, Rockville, MD 20857, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Kessler
authors.forename: A E
authors.initials: AE
authors.lastname: Hass
authors.forename: K L
authors.initials: KL
authors.lastname: Feiden
authors.forename: M
authors.initials: M
authors.lastname: Lumpkin
authors.forename: R
authors.initials: R
authors.lastname: Temple
mesh_terms: D017277:Drug Approval; D004345:Drug Industry; D015507:Drugs, Investigational; D005858:Germany; D007564:Japan; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational