• ISPE Membership
• About ISPE
• 

The US Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services.  The current Commissioner of Food and Drugs is Dr. Margaret A. Hamburg. 

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.
FDA consists of the centers/offices listed below:

Center for Drug Evaluation and Research (CDER)  - regulates drugs
FDA Drug Site |  More Information on CDER

Center for Biological Evaluation and Research (CBER)  - regulates biologics
CBER Web Site | More Information on CBER

Center for Devices and Radiological Health (CDRH)  - regulates medical devices and radiation emitting products
CDRH Web Site | More Information on CDRH

Center for Food Safety and Applied Nutrition (CFSAN) - regulates food and cosmetics
CFSAN Web Site |More Information on CFSAN

Center for Veterinary Medicine (CVM) - regulates animal feed and drugs
CVM Web Site | More Information on CVM

Center for Tobacco Products (CTP) - regulates tobacco products
CTP Web Site | More Information on CTP

National Center for Toxicological Research (NCTR)  - conducts research to further FDA's mission
NCTR Web Site | More Information on NCTR

Office of the Commissioner (OC)  - responsible for implementing FDA's mission
OC Web Site

Office of Regulatory Affairs (ORA)  - leads all field activities
ORA Web Site | More Information on ORA 

FDA's Regulatory Information Page
This page contains links to a variety of regulatory topics.

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.

FDA Basics For Industry
FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.

General Navigation Guide for Manufacturers of FDA-Regulated Products and Start-ups 
The general navigation guide below is provided in the event it may be helpful to companies wondering if their planned activities would be subject to regulation by FDA. 

Legislation Affecting FDA 
This page provides an historical overview of legislation affecting FDA, and provides links to many of the laws.   
Quick Answers FDA publishes quick answers to these questions (and more) in their FDA Basics section

• What does FDA do?
• What does FDA regulate?
• What doesn't FDA regulate?
• How is FDA organized?
• What does FDA inspect?
• How can I share my ideas and suggestions with FDA?
• What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
• What is a recall?
• What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
• How many people are employed by FDA and in what areas do they work?
  Is it true that FDA is approving fewer drugs recently?Is it true that FDA is approving fewer drugs recently?

Videos

• FDA Track:  Agency Wide Program
  This video explains the FDA Track program, and how it will increase transparency at FDA.
• FDA's Global Transformation
• Articles and Information on FDA
• History of FDA
• FDA Inspections
• Enforcement Story
  The Enforcement Story describes FDA's accomplishments and enforcement-related activities in all product areas over which FDA has jurisdiction.
• 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

My ISPE

• Privacy Policy
• Contact Us
• Terms of Use