Business Law
October 11, 2000
The FDA has many responsibilities which include overseeing the production of
safe foods and the manufacture of safe and effective drugs and medical devices. The
FDA has responsibility for protecting the rights and safety of patients in the clinical
trials of investigation medical products. The FDA also has to review and approve in a
timely manner the safety and efficiency of new drugs, biologics, medical devices, and
animal drugs. They have to monitor the safety and effectiveness of new medical
products after they are marketed and acting on the information collected. The FDA is
responsible for seeing that the public has access to truthful and non-misleading product
information by: monitoring the promotional activities of drug and device manufacturers,
and regulating the labeling of all packaged foods.
Science is a big part of the FDA organization. The scientific evidence needed to
back up FDAs legal cases is prepared by the agencies 2,100 scientist, including 900
chemist and 300 microbiologist, who work in 40 laboratories in the Washington, D.C.,
area and around the country. Some of these scientist analyze samples to see, or
example if products are contaminated with illegal substances. Other scientist review
test results submitted by companies seeking agency approval for drugs, vaccines, food
additives, coloring agents and medical devices. The FDA also operates the National
Center for Toxicological Research. They investigate the biological effects of widely
used chemicals. The agency also runs the Engineering and Analytical Center, which
test medical de ...