1. “I will never get out of this! There are two of me now:” “Living with her was like living with a coffin: Yet I still depended on her, though I did it regretfully.”

2. Founder: Harvey Washington Wiley Before the FDA, it was legal to put anything on labels, sell any food, and sell any type of medicine. Food and Drug Act of 1906: illegal for certain chemicals to be used and untrue labeling

3. Bugs and other things placed in food and medicine before there was regulation. In the late 1900’s people felt that the FDA should be doing more to make sure the drug manufacturers were concerned about the people

4. Long process that is very expensive Many start out in the first steps and few actually make it to the shelf. All steps regulated by the FDA.

5. Target Identification and Validation Screening – Finding the antibodies Pre-Clinical testing – Find dosage and lethal dosage using animal testing

6. Phase Trials 1 – 20-80 people, 1- 1.5 years, dosage and safety Phase Trials 2 – 100-300 people, 2 years, effectiveness & side effects Phase Trials 3 – 1000-3000 people, 3-3.5 years, adverse reactions & long term use

7. Results are sent to the FDA for approval – Depending on the drug and the company the drug could go through the fast track. – Must be safe and effective Tests still preformed to insure safety

8. Available at most any store Ranges from something for a headache to something for allergies Highly researched and studied Some are kept in just a pharmacy Drug facts

9. Veterinarian, dentist, optometrist, doctor, or medical practitioner Rx-Only drugs or legend drugs Can become an over-the- counter drug

10. Anything that replaces normal medical procedures or medicines Herbs, aromatherapy, acupuncture, chiropractor, energy medicine, and mind- body medicine

11. Fast-track is not a good program – Recalls have risen 4%. Mostly founded by the drug companies – Influences decisions Trying to become stricter on regulations of devices