CDER Archives

CDER Archives

Official records, older publications and superceded but still useful information.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

Drug Information Approved Prior to 1998

• CDER Freedom of Information Office Electronic Reading Room - Provides information on how to request FDA information under the Freedom of Information Act.
• 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.

Superceded Guidances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 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 perfomance 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.
• 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)

Some of documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with full installation instructions.

FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
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