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CDER Archives


Official records, older publications and superseded but still useful information.   This classification is currently under development and is not comprehensive.

Drug Information Approved Prior to 1998

Superseded Guidances

Archival Reports & Publications

  • Annual Adverse Drug Experience Report:  1996 (Published 10/30/1997, Posted 4/6/1998) or 1995 PDF document (Published 1/27/96, posted 2/3/1997).  This report presents a descriptive overview of the evaluable, postmarket adverse drug experience (ADE) cases received by the US Food and Drug Administration (FDA) during calendar year 1995 and 1996.
  • CDER 2002 Report to the Nation: Improving Public Health Through Human Drugs HTML or PDF (705 KB) (5/13/2003).    Statistics on CDER's 1995-2002 performance for drug reviews and post-marketing risk assessment and other highlights from 2002.    Covers PDF (196 KB).    MS PowerPoint Slides (134 KB): Graphs in report for use in presentations.    [Earlier reports located in CDER Archives.]
  • CDER 2001 Report to the Nation: Improving Public Health Through Human Drugs [HTML] or [PDF] (633 KB) (5/15/2002).  Statistics on CDER's 1995-2001 performance for drug reviews and post-marketing risk assessment and other highlights from 2001.   MS PowerPoint Slides (156 KB).  Graphs in report for use in presentations.
  • CDER 2000 Report to the Nation: Improving Public Health Through Human Drugs [HTML] or [PDF] (663 KB) .  Statistics on CDER's 1993-2000 performance for drug reviews and post-marketing risk assessment and other highlights from 2000.   MS PowerPoint Slides (203 KB).  Graphs in report for use in presentations.
  • CDER 1999 Report to the Nation: Improving Public Health Through Human Drugs [HTML] 5/25/2000 or [Acrobat] (5/17/2000)..  Statistics on CDER's 1993-1998 performance for drug reviews and post-marketing risk assessment and other highlights from 1998.   MS PowerPoint Slides (985 KB).  Graphs in report for use in presentations.   Earlier reports located in CDER Archives.
  • CDER 1997 Report to the Nation: Improving Public Health Through Human Drugs PDF (Issued 6/1/98, Posted 6/3/98). 
    Statistics on CDER's 1993-1997 performance for drug reviews and post-marketing risk assessment and other highlights from 1997, formerly called Report to Industry.  MS PowerPoint Slides (249 KB). Graphs in report for use in presentations.
  • Mifepristone (Mifeprex) Index of Redacted Documents (Posted 1/30/2002)
  • Prescription Drug User Fee Act Report Fiscal Year 1996.
  • Prescription Drug User Fee Act Report Fiscal Year 1995.
  • SAS Drug Formulation Stability Program
    [March 1992 programs moved from Gopher as legacy files]. (Created 7/28/1997; Posted 7/29/1997)

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FDA/Center for Drug Evaluation and Research
Last Updated: April 27, 2001
Originator: OTCOM/DML
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