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US drug and biologic approvals in 1998
Author(s) -
Spilker Bert,
FitzSimmons Stacey,
Horan Michael
Publication year - 1999
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/(sici)1098-2299(199912)48:4<139::aid-ddr1>3.0.co;2-v
Subject(s) - food and drug administration , drug , drug approval , medicine , pharmacology , medical prescription , new drug application , prescription drug , approved drug , business
The Prescription Drug User Fee Act of 1992 enhanced review resources for the Food and Drug Administration (FDA). The past 3 years have seen an unprecedented approval of 122 new drugs and 28 new biologics. Information is provided on the 39 new products approved by the FDA in 1998. Drug Dev. Res. 48:139–153, 1999. © 1999 Wiley‐Liss, Inc.