RAPS FDA History Chapter 1

  1. Under which branch of government does FDA fall?
    Executive branch US department of Health and Human Services
  2. $$$ worth of goods that FDA regulates today
    $1 Trillion
  3. In the 19th centruy, how were food and drugs regulated
    States exercised principle control over domestically produced and distributed food and drugs.  Federal authority was restricted to imported food and drugs. 
  4. What was the first federal law dealing with consumer protection and theraeutic substances?
    The Vaccine Act if 1813
  5. Who is credited as the father of US food and drug law?
    Dr. Harvey W. Wiley
  6. When able-bodied volunteers were asked to consume varying amounts of quationable food additives to determine their impact on health, it was called...
    The poison squad experiment
  7. Which book was the precipitating force behind meat inspection law and comprehensive food and drug law?
    Upton Sinclair's The Jungle
  8. When and by whom was the Food and Drug Act first signed?
    Theodore Roosevelt 30 June 1906
  9. The Food and Drug Act of 1906 was also known as?
    The Wiley Act
  10. How many Centers are there within FDA?
    • 9.
    • Office of the Commissioner
    • Center for Biologics Evaluation and Research (CBER)
    • Center for Devices and Radiological Health (CDRH)
    • Center for Drug Evaluation and Research (CDER)
    • Center for Food Safety and Applied Nutrition (CFSAN)
    • Center for Tobacco Products (CTP)
    • Center for Veterinary Medicine (CVM)
    • National Center for Toxicologial Research (NCTR)
    • Office of Regulatory Affairs (ORA)
  11. Which center is responsible for efficient and effective implementation of FDA's mission? 
    The Office of the Commissioner (OC)
  12. Which office of FDA represents FDA in court proceedings, and rovices legal advice and policy guidance for FDA programs?
    Office of the Chief Council
  13. Which office of FDA provides strategic leadership, coordination and expertise to support scientific excellence, innocation and capacity?
    Office of the Chief Scientist
  14. Which offices report to the Office of Chief Scientist?
    • Office of Counterterrorism and Emerging Threats
    • Office of Scientific Integrity
    • Office of the Ombudsman
    • Office of Science and Innovation
    • Office of Critical Path Programs
  15. Which office is the focal point for all international FDA matters, particpating in such programs as the Trilateral Corporation, WHO, Pan American Health Organization, Codex Alimentarious, and The International Conference on Harmonization?
    Office of International Programs
  16. Which office serves as the agency focal point for special programs and initiatives that ae cross-cutting, scientific and/or regulatory in nature?
    Office of Special Medical Programs
  17. Which office coordinates internal and external review of pediatric science, safety, ethical and international issues as mandated by law and agency activities
    Office of Special Medical Programs
  18. Which office oversees the implementation of te orphan products provisions of the FD&C act?
    Office of Special Medical Programs
  19. Which office has executive leadership tothe office of good clinical practice?
    Office of Special Medical Programs
  20. Which office oversees the functions of the Office of Combination Products as provided in the FD&C Act?
    Office of Special Medical Programs
  21. Which office works with all FDA centers to provide consistent operations and seek continuous improvements in the agency advisory committe program?
    Office of Special Medical Programs
  22. Which office serves as the liaison with the Office of the Secretry, the DHHS Committee Management Office, all of FDA's center advisory support staff and other organizations/offices within FDA?
    Office of Special Medical Programs
  23. Which office is responsible for ensuring that all FDA committee managememt actiities are consistent with the provisions of Federal Advisory Committee Act, departmental policies, and related regulations and statutes?
    Office of Special Medical Programs
  24. Which offices report to the Office of Special Medical Programs?
    • Office of Combination Products
    • Office of Good Clinical Practice
    • Office of Orphan Product Development
    • Office of Pediatric Therapeutics
  25. Which center evaluates all new prescription and over-the-counter drugs before they are sold to ensure that they are safe and effective?
  26. Which center regulates biological products for disease prevention and treatment, including vaccines, protein-based products such as monoclonal antibodies and cytokines and bllod, blood products such as plasma, blood-derived proteins, tests used to screen blood donors and devices used to make blood products?
  27. Which center is tasked with ensuring that all new medical devices are safe and effective befoe the are marketed, and also regulates devices and radiation emitting products such as microwaves, TVs, cell phones, and lasers to ensure they meet radiation safety standards?
  28. Which center helps ensure that animal-food products are safe, regulates the manufacture and distribution of food additives and drugs that will be given to animals, and evaluates the safety and effectiveness of drugs use to treat companion animals?
  29. Which center is responsible for the safety of almost all food consumed in the US wit the exception of meat, poultry, and some egg products?
  30. For those consumer foods not regulated by CFSAN, who is responsible?
    US Department of Agriculture is reponsible for the safety of meat, poultry and some egg products. 
  31. Which system, which places preventative controls as the most contamination-prone points in the production process, did CFSAN (Center for Food Safety and Applied Nutrition) pioneer?
    Hazard Analysis and Critical Control Point (HACCP) System
  32. Which center conducts research and provides advice and training necessary for science-based decision making and developing sound regulatory policy?
    National Center for Toxicological Research (NCTR)
  33. Which center is responsible for overseeing the implementation of the Family Smoking Prevention and Tobacco Control Act?
    Center for Tobacco Products (CTP)
  34. When did the Family Smoking Prevention and Tobacco Control Act become law?
    22 June 2009
  35. Which Office advises and assists the FDA commissioner and other key officials on regulations and compliance matters, evaluates and coordinates all proposed FDA legal actions to asertain compliance with regulatory policy and enforcment objectives?
    Office of Regulatory Affairs
  36. Which office is the lead for all FDA field activities and executes direct line authority over all field operations?
    Office of Regulatory Affairs
  37. Which document provides guidance to FDA field stff on the inspectional process used to assess a manufacturer's compliance with the Quality System Regulations?
    Office of Regulatory Affairs
  38. What does FTC stand for?
    Federal Trade Commission
  39. Which Act prohibits unfair or deceptive acts or practices in or affecting commerce, the dissemination of any false advertisment for the purpose of inducting the purcase of food, drugs, devices, services, or cosmetics?
    Federal Trade Commission Act
  40. FTC has primary jurisdiction over the advertising of products other than ____________ (which is regulated by FDA per a 1971 memorandum of understanding)?
    restricted devices, drugs, and OTC drugs
  41. What is the FTC's secure, online complaint database?
    Consumer Sentinel
  42. What is the name of the federal agency within the Department of Health and Human Services responsible for medicare, medicaid and other programs?
    Center for Medicare and Medicaid Services (CMS)
  43. Which Center has jurisdiction over the Health Insurance Portability and Accountability Act, enacted in 1996 to create a national standard for protecting the privacy of patients personal health information (PHI)?
  44. Healthcare entities may not ue or disclose ______ without an individuals written authorization with only some exceptions as permitted and required by law.
    Protected Health Information (PHI)
  45. HIPAA stands for...
    Health Insurance Portability and Accountability Act
  46. Which commission is responsble for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packagesand baby toys?
    Consumer Product Safety Commission
  47. Name three products that are expressly exempt from the from regulation under the Consumer Product Safety Act (CPSA) because they are subject to another goverment jurisdiction?
    Tobacco, pesticides and motor vehicles
  48. Give an example of how FDA & CPSC work cooperativly for consumer protection.
    Articles employed in the preparation or holding of food that malfunctions and causes contamination or spoilage. FDA may take action against manufacturers of food that has been contaminated or spoiled by these articles. 
  49. Which commission's primary mission is to protect the investing public and maintain the integrity of the securities market?
    Securities and Exchange Commission (SEC)
  50. True or False.

    FDA employees may report suspicious public statements to the attention of the SEC?
  51. Which act created an administration at the federal level witing the department of labor who's mission is to prevent work-related injuries, illnesses, and deaths by issuing and enforcing rules (called standards) for workplace safety and health?
    Occupational Safety and Health Act (OSH) 
  52. Which act provides for federal regulationof beer, wine, and distilled spirits, and establishes requirements for packaging used to hold alcohol over and above those imposed by FDA for foods under the FD&C act. 
    Federal Alcohol Administration Act (FAAA)
  53. Which bureau administers the FAAA?
    The Treasury Department's Alcohol nd Tobacco Tax and Trade Bureau (TTB)
  54. Which department has oversight of dairy, poultry, fruit and meat products except for shell eggs, for which FDA and USDA share jurisdiction?
    United States Department of Agriculture (USDA)
  55. Which components of egg manufacturing are regulated by USDA?
    Egg washing, sorting, egg breaking, and pasteurizing operations
  56. Define the term "poultry" (according to the Poultry Product Inspection Act)
    any domesticated bird
  57. FDA regulates many food groups, but ______ is one of the few FDA-regulated food groups further regulated under a system of risk prevention controls known as ___________.
    • 1. Seafood
    • 2. Hazards Analysis and Critical Control Points (HACCP)
  58. The mission of _______ is to protect human health and the environment, which includes jurisdiction over the public water supply.
    Environmental Protection Agency (EPA)
  59. The passage of which Act (and in which year) implicitly repealed FDA's authority under the FD&C act over drinking water?
    Safe Drinking Water Act (SWDA) in 1974
  60. Although anitmicrobial surface solutions applied to counter tops, table tops, food processing equipment, cutlery, dishware or cookware, to sanitize such objects after they have been washed are regulated as "pesticide chemicals" by EPA, this exception is instead regulated by  FDA as they are considerd food additives.
    anitmicrobial surface solutions used to sanitize food packaging materials
  61. True or False.  FDA, USDA, and EPA share responsibility for regulating pesticides.
    True - EPA determines the safety and effectiveness and establishes tolerance levels for the residues on feed crops, as well as on raw and processd foods, while FDA and USDA are reponsible for monitoring the food supply to ensure that pesticide residues do not exceed allowable levels. 
  62. Illegal drugs with no approved medical use, such as heroin and cocaine, are under the jurisdiction of which federal agency?
    Drug Enforcement Agency (DEA)
Card Set
RAPS FDA History Chapter 1