Who We Are and What We Do

Contents On This Page

• Who We Are
• What We Do
• What We've Accomplished
• Regulatory Authority
• Training
• CDER History
• How to Contact Us

Who We Are:

• CDER Personnel Directories -
  CDER Key Officials
  CDER Reference Guide - This directory lists key CDER personnel by office.
  Searchable HHS Employee Phone Directory (Searchable database by agency)
• Organization Charts - Organization charts also link to CDER office and division home pages.
• CDER Office and Subject Home Pages - Links to CDER office, division, and subject home pages.

What We Do:

• CDER Drug Product Applications  What you need to know to file applications for a regular or an emergency investigational drug product, a new drug, or a generic drug.
• CDER Handbook (Updated 5/19/1999) - The CDER Handbook describes the Center's processes and activities.
  • Spanish Edition (1 MB) (4/2/2001)
• FDA Consumer Magazine - From 1989 to the present.
• FDA Fact Sheets about Drugs (includes Spanish Language versions)
  • FDA Fact Sheet about CDER: Improving Public Health: Promoting Safe and Effective Drug Use. [HTML] or [PDF] (updated 8/2003)
• FDA News - Latest Information from the U.S. Food and Drug Administration - Press releases and additional information not found on this CDER home page.
• From Test Tube to Patient: Improving Health Through Human Drugs (2/2006)
• Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations. [HTML] or [PDF] (3/12/2003)
• Human Drug Advisory Committees  Links to meeting transcripts and related information.
• Managing the Risks from Medical Product Use: Creating a Risk Management Framework. (Posted 5/10/1999) Executive Summary .  Full Report (164 pages) .
• Manual of Policies and Procedures (MaPPs)  CDER's official policies and procedures manual.
• Frequently Asked Questions About CDER
• Small Business Assistance Program  What you need to do to file an application for marketing a new drug product.
• Small Business Guide to FDA  About FDA's organization, procedures, policies, and regulations.

What We've Accomplished:

• News Along the Pike; September 2006 [HTML] or [PDF] [Previous issues]
• CDER 2007 Update: Improving Public Health Through Human Drugs. [HTML] or [PDF] (530 KB) (7/31/2008). (Formally known as Report to the Nation.) Color covers PDF (1,009 KB). Graphs in report for use in presentations. [Earlier reports located in CDER Archives.]
• CDER Data Briefing 1996-2006: MS PowerPoint Slides (92 KB), PDF (110 KB), accessible HTML version. (8/10/2006).
• New Drug Approval Reports Status reports of drug approvals by calendar year.
• Prescription Drug User Fee Act (PDUFA) Reports to Congress

Regulatory Authority:

• Laws Enforced by the FDA and Related Statutes

Training

• CDERLearn Online educational tutorials

CDER History

• FDA Centennial at CDER (5/2006)
• A Brief History of the Center for Drug Evaluation and Research

Employment Opportunities at CDER

How to Contact Us:

• Drug information, policy questions, and general web site feedback
• Ombudsman  The function of the CDER Ombudsman parallels that of the FDA Ombudsman, but permits those both inside and outside the Center an avenue for getting complaints involving CDER programs resolved at a level closer to the source.
• Small business inquiries: Ron Wilson ronald.wilson@fda.hhs.gov, (301) 796-3177

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Last Updated: September 26, 2008

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