1999•Drug Development ResearchRequires access
US drug and biologic approvals in 1998
Bert Spilker, Stacey R. Fitzsimmons, Michael J. Horan
Open publisher page 5 citations
Abstract
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.