FDA Regulatory Links

 

FDA Home Page
www.fda.gov 

FDA Freedom of Information Index
www.fda.gov/foi/electrr.htm 

FDA Warning Letters
www.fda.gov/foi/warning.htm 

FDA Recalls
www.fda.gov/opacom/Enforce.html 

FDA Inspection Guides
http://www.fda.gov/iceci/inspections/inspectionguides/default.htm

CFR Titles
www.access.gpo.gov/nara/cfr/cfr-table-search.html 

U.S. Code
uscode.house.gov

CBER Guidelines
http://www.fda.gov/cher/guidelines.htm 

CDER Guidelines
www.fda.gov/cder/guidance/index.htm 

CDRH Guidelines
www.fda.gov/cdrh/ggpmain.html 

CDRH Documents
www.fda.gov/cdrh/topindx.html 

CGMP
www.fda.gov/cder/dmpq/index.htm 

Investigation Operations Manual
http://www.fda.gov/iceci/inspections/iom/default.htm

FDA Medwatch (Medical Product Reporting Program)
www.fda.gov/medwatch 

FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)
directory.psc.gov/employee.htm

 

Overview about one of the most important and biggest Health Agencies in the world. The FDA - The Food and Drug Administration

 

The FDA Food and Drug Administration is on of the most important Health Agencies in the word. The US Market is a multi billion $ market related to pharmaceutical and food products.

FDA regulates a couple of different products on the American market. The two main sections are the food products and ingredient and the drug products. Beside these two areas FDA – Food and Drug Administration controls also Consumer and Medical as well as Radiation Products. 25 % of all products on the American market are controlled by this Agency.

The FDA – Food and Drug Administrations employs more than 10.000 people. Most of them are scientists. The yearly budged is about 1.6 billion per year.

The main mission of the FDA – Food and Drug Administration is to protect the life of every American inhabitant by making sure that foods and drug products are safe and efficient.

The FDA is an agency within the United States Department of Health and Human Services with a direct reporting line to the white house.

The agency is currently organized into the following eight subdivisions:

1. The Center for Food Safety and Applied Nutrition (CFSAN)
This center regulates all Food products and nutrition products

2. The Center for Drug Evaluation and Research (CDER)
This Center is responsible for the release and control of Drug Products

3. The Center for Biologics Evaluation and Research (CBER)
This Center is responsible for the release and control of biological Drug Products

4. The Center for Devices and Radiological Health (CDRH)
Control of medical devices like heart valves and also responsible for all radiological products and devices

5. The Center for Veterinary Medicine (CVM)

6. The National Center for Toxicological Research (NCTR)

7. The Office of Regulatory Affairs (ORA)

8. The Office of the Commissioner (OC)

The FDA – Food and Drug Administration is headed by Commissioner Andrew von Eschenbach, who was confirmed by the Senate on December 7, 2006.

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