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- 2. Food & Drug Administration (FDA) 1862, started with a single chemist in the USDA 1927, Bureau
- 3. Adulteration and misbranding of foods & drugs have always been a problem in the U.S. The
- 4. http://www.fda.gov/cder/about/history/Graphics/OilKingLrg.jpg
- 5. http://www.fda.gov/cder/about/history/Gallery/gallery21.htm
- 6. Harvey Washington Wiley, chief chemist concerned about chemical preservatives, initiated "poison squad" experiments Healthy volunteers consumed
- 7. Wiley became convinced that chemical preservatives should be used in food only when necessary That the
- 8. Food and Drugs Act of 1906 First nationwide consumer protection law made it illegal to distribute
- 9. There were however, shortcomings in the 1906 law Law prevented blatant fraud, but it did not
- 10. http://www.fda.gov/oc/history/slideshow/Slide_182_139.html Flavoring Extract Bottle thick glass obscures how much expensive flavoring extract is really in the
- 11. Lash-Lure, an eyelash dye that blinded many women http://www.fda.gov/oc/history/
- 12. A disaster in 1937 prompted Congress to act A Tennessee drug company marketed a form of
- 13. http://www.fda.gov/cder/about/history/Page18.htm Elixir Sulfanilamide
- 14. 1938 Federal Food, Drug, and Cosmetic Act For the first time, required companies to prove the
- 15. Currently the FDA is charged with: Safeguarding the nations food supply, by ensuring that all ingredients
- 16. Medical products need to be proven safe and effective before they can be used by patients
- 17. Drug Review & Approval
- 19. The majority of prospective new drugs fail testing, many never make it passed the pre-clinical stage
- 20. If a compound shows promise during the pre-clinical phase the drug maker may decide to move
- 21. Investigational New Drug Application (IND) The IND is reviewed by both the FDA and a local
- 22. After approval by the IRB and the FDA, clinical trials can begin There are up to
- 23. Phase I Studies Conducted in healthy volunteers, between 20 to 80 Goal is to determine safety
- 24. Phase II Studies Shift in emphasis from safety to effectiveness Collection of preliminary data on whether
- 25. Phase III Studies If effectiveness is shown during phase II the study is expanded to a
- 26. Phase IV Studies Occur after a drug is approved Explore other aspects of the drug such
- 27. New Drug Application (NDA) Once clinical trials are finished the sponsor places a formal request with
- 28. Review Process The review team analyzes all aspects of the study results looking for possible problems,
- 29. If the FDA decides that the benefits of the drug outweigh any risks the drug can
- 30. Accelerated Approval Given to drugs for serious and life-threatening illnesses that lack satisfactory treatments Uses surrogate
- 31. http://www.fda.gov/cder/handbook/develop.htm
- 32. Abbreviated New Drug Application (ANDA) Provides for the review and ultimate approval of a generic drug
- 33. Bioequivalence In order to demonstrate bioequivalence scientists measure the time it takes the generic drug to
- 34. Orphan Drugs In 1982 Congress passed the Orphan Drug Act The goal was to promote the
- 35. Adverse Events Reporting System (AERS) The FDA requires manufacturers to report adverse drug reactions Health care
- 36. If a drug has severe side effects, but is kept on the market a black box
- 37. Recent Drug Controversies Vioxx, voluntarily withdrawn due to increases in heart attacks & strokes Prempro, Premarin;
- 38. If you have questions about medications your or your family are taking: http://www.fda.gov/medwatch/index.html
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