Quality and safety of treatments are enabled by the FDA

Drug importation act (1880s) required the inspection of medicines from abroad
early 1900s showed that drug regulation was important to public health, and that public health was important
- biologics control act of 1902
- The jungle
FDA was established by 1933 (formerly the bureau of chemistry under USDA)
- FD&C act extended FDA authority to cosmetics and devices
- Big success of the FDA was the restriction of thalidomide, which caused birth defects
National center for toxicology was established to understand long-term effects of chemicals and the environment for public health
NIH transferred regulation of biological products to the FDA
- prescription drug user fee act passed in 1992 to increase speed of approval of new drugs
FDAAA act greatly increased responsibilities of the FDA in 2007.
FDA also tries to educate health care providers about the use and safety of drugs and treatments through its regulation of labels and advertising
FDA also performs research regarding products it regulates

Drug and Biological product life cycle

research hopes to yield some drug material of interest
- Animal safety studies
- initial toxicity profile

IND application allows for transport of new drugs across state lines for research purposes
- phase 1-4