Chapter 14. The Food and Drug Administration. FDA Prehistory. 1862, President Lincoln appointed first director of Department of Agriculture 1883 Request for petition to pass laws prohibiting adulteration & misbranding of foods and drugs.
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The Food and Drug Administration
…with the hot weather there descended upon Packingtown a veritable Egyptian plague of flies; there could be no describing this--the houses would be black with them. There was no escaping; you might provide all your doors and windows with screens, but their buzzing outside would be like the swarming of bees, and whenever you opened the door they would rush in as if a storm of wind were driving them. (Chapter 10)
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The Crystaldyne Pain Reliever, 1996Similar to The Stimulator
The Stimulator is essentially an electric gas barbecue grill igniter outfitted with finger grips. When pressed against the skin, the devices sparks and causes a small electric shock. Makers of the device claim it can relieve headaches, back pain, arthritis, stress, menstrual cramps, earaches, sinus, nosebleeds, flu and other ailments.
Because of its medical claims, the Stimulator is considered a medical device. The manufacturers, however, have not complied with any FDA regulations that govern the marketing of medical devices. The companies have submitted no information to FDA showing that the device is either safe or effective...
…FDA (also) regulates the labeling of products under its jurisdiction. This information, which must be rigorously truthful, well documented, and not misleading, plays a major role in protecting consumers and the public health. The FDA-regulated food label is helping shoppers eat a healthy diet; the labeling of drugs and medical devices gives prescribers and patients reliable guidance about the safety and effectiveness of health care products.
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·Nitric Oxide-induced shock
·Other proprietary applications
·Established patent position
·Proved NO scavenger concept in sheep, dog, pig, and mouse models
·Completed Phase 1 safety study and initial Phase 1/2 patient trial for NO-induced shock
·Completed continuous infusion and dose escalation (Phase 2) clinical trial
·Randomized, controlled Phase 3 trial to commence in 2001