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U.S. drug and biologic product approvals during 1993
Author(s) -
Beary John F.,
Robert Eaton C.,
Copmann Thomas L.,
Wierenga Dale E.
Publication year - 1994
Publication title -
drug development research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.582
H-Index - 60
eISSN - 1098-2299
pISSN - 0272-4391
DOI - 10.1002/ddr.430320302
Subject(s) - food and drug administration , drug , medical prescription , medicine , prescription drug , business , product (mathematics) , drug approval , pharmacology , geometry , mathematics
Drugs remain a key element in the effective containment of health care costs. In 1993, 29 new drugs were approved for marketing by the US Food and Drug Administration (FDA). These entities, according to a 1993 Office of Technology Assessment study, each took on average 12 years and $359 million each to discover and develop. The FDA reported that the average review time for these entities was 26.5 months, some 3 months less than reported in 1992. Under the prescription Drug User Fee Act of 1992, which will generate an additional $327 million over the period 1993–1997, the FDA will hire an additional 600 review staff.