ENGINEERING PHARMACEUTICAL INNOVATION
ENGINEERING PHARMACEUTICAL INNOVATION
communities of practice
affiliates and chapters
career exchange
regulatory resources
publications
education and training
Professional Certification
join IPSE
Keyword Search:
  
Site Map
 
What our members say

Since joining ISPE just two years ago, my professional life has become much more fulfilling. I have made numerous business contacts because of the great networking opportunities. ISPE has kept me in touch with the latest in global regulatory affairs and I'm learning something new everyday from the Baseline® Guides. As a consultant, this has allowed me to provide my clients with the most up-to-date and relevant information available.

Gopal Nair, CEO
GRASP Enterprise, India

Watch the Video:
True Stories: What it means to be an ISPE Member - (WMV, 16 MB) (Click to begin, or right-click to download and view later)

Regulatory Resources
Overview of the US Food and Drug Administration

The US Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services and consists of the eight centers/offices listed below:

  1. Center for Drug Evaluation and Research (CDER)  - regulates drugs
    CDER Web Site |  More Information on CDER
  2. Center for Biological Evaluation and Research (CBER)  - regulates biologics
    CBER Web Site | More Information on CBER
  3. Center for Devices and Radiological Health (CDRH)  - regulates medical devices and radiation emitting products
    CDRH Web Site | More Information on CDRH
  4. Center for Food Safety and Applied Nutrition (CFSAN) - regulates food and cosmetics
    CFSAN Web Site |More Information on CFSAN
  5. Center for Veterinary Medicine (CVM) - regulates animal feed and drugs
    CVM Web Site | More Information on CVM
  6. National Center for Toxicological Research (NCTR)  - conducts research to further FDA's mission
    NCTR Web Site | More Information on NCTR
  7. Office of the Commissioner (OC)  - responsible for implementing FDA's mission
    OC Web Site
  8. Office of Regulatory Affairs (ORA)  - leads all field activities
    ORA Web Site | More Information on ORA | FDA District Offices and Regions

FDA's Organizational Charts
This page explains the organization of the Food and Drug Administration.  It contains links to the entities within FDA, and links to their organizational charts.

The FDA's mission is to:

  • Promote and protect the public health by helping safe and effective products reach the market in a timely way
  • Monitor products for continued safety after they are in use
  • Help the public get the accurate, science-based information needed to improve health.

More Information. . .

Articles and Information on FDA

History of FDA

FDA Inspections

Enforcement Story 2006 (published March 2007)

Consequences of Non-Compliance with FDA

Additional information for the FDA regulated industry (including recalls, recent 483 notices, meeting notices, adverse event reports, etc.) can be obtained at the FDA’s Information for FDA-Regulated Industry page and the Laws Enforced by the FDA and Related Statutes page.

Consequences of Non-Compliance With FDA

Sub ISPE image

© 2008 International Society for Pharmaceutical Engineering. All rights reserved.