CDER Archives

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FDA/Center for Drug Evaluation and Research

Official records, older publications and superseded but still useful information.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

Contents On This Page

Drug Information Approved Prior to 1998
Superseded Guidances
Archival Reports & Publications

Drug Information Approved Prior to 1998

CDER Freedom of Information Office Electronic Reading Room Contact FOI directly to obtain information not available on the CDER web site.
FDA Drug Approval Packages. New Drug Approvals or Generic Drug Approvals. Covers selected drugs approved as early as 1979.
FDA Drug and Device Product Approval List: Legacy Information from February 1991 through August 1996. This is an official publication about the Drug and Device Product Approvals. This publication includes the new approvals for Drugs, Medical Devices, Biologics and Veterinary Drugs.
Synthetic Generic Conjugated Estrogens. CDER announced that it will not approve synthetic generic forms of the estrogen-replacement drug Premarin.

Superseded Guidances

Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients. Also in .

Archival Reports & Publications

Annual Adverse Drug Experience Report: 1996 (Published 10/30/1997, Posted 4/6/1998) or 1995 (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 2005 Report to the Nation: Improving Public Health Through Human Drugs. HTML or PDF (495 KB) (8/15/2006). Statistics on CDER's 1995-2005 performance for drug reviews and post-marketing risk assessment and other highlights from 2004. Color covers PDF (93 KB). MS PowerPoint Slides (220 KB): Graphs in report for use in presentations. [Earlier reports located in CDER Archives.]
CDER 2004 Report to the Nation: Improving Public Health Through Human Drugs HTML or PDF (492 KB) (8/22/2005). Statistics on CDER's 1995-2004 performance for drug reviews and post-marketing risk assessment and other highlights from 2004. Covers PDF (109 KB). MS PowerPoint Slides
CDER 2003 Report to the Nation: Improving Public Health Through Human Drugs HTML or PDF (683 KB) (5/24/2004). Statistics on CDER's 1995-2003 performance for drug reviews and post-marketing risk assessment and other highlights from 2003. Covers PDF(196 KB). MS PowerPoint Slides (134 KB): Graphs in report for use in presentations.
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 (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.
Center for Drug Evaluation and Research Fact Book 1997 This publication provides an overview of the diversity of activities and responsibilities within the Center.
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)
FDA's Drug Review and Approval Times(7/27/2001)
Conversation with Stakeholders Report-April 1999
Office of Drug Safety Annual Report 2001
Reviewer Diagram Project (6/23/1999). Several approaches to reviewing drug applications
FDA Medical Bulletin Important Information for Health Professionals from the U.S. Food and Drug Administration.

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Last Updated: October 11, 2006