The FDA and Tobbaco Regulartion

Preferred language style: English (U.S.)

Cases are to be approached with a decision-making orientation of a single individual at some specific point in time. Students should take the approach that allows them to show the greatest depth of insight into the case.

1. Select a single person whose role you will play in the case. (Initially these will be assigned beforehand). Normally this person will be mentioned by name or by position in the case. Once you have chosen an individual, you must be that person as much as possible for the analysis. You cannot imbue this person with “desirable” characteristics that differ from those directly given or indirectly deducible from case facts and evidence. You are stuck with this person’s strengths, weaknesses, history, preferences, power and limitations. Once you have chosen an individual, you cannot assume that this person possesses all case facts. If there are case facts that your individual would not normally know, you must at least give a hint as to how this individual obtained this information. 2. Select the decision to be made (e.g. the most difficult, the most important, and/or the most interesting). This decision can be one that has been made before the case begins, that occurs during the period of the case, or that must be faced at some time subsequent to the end of the case. The decision selected should be a challenging one and should provide significant opportunity for the student to demonstrate a thorough understanding of the issue. 3. Select a single point in time. Once you have chosen, you are stuck with the information that was known at that time. You cannot assume this individual has knowledge of case facts that are known to you, but that had not occurred by the time chosen for your analysis. There is one exception to this limitation. For the person you have chosen, you may use future actions/statements by that person as indications of that individual’s character. Presumably the individual’s values are known to that individual, but the reader finds these out only during the case events, some of which may take place after your selected point in time. 4. Do not summarize the case. Use case facts only to support your analysis; they have no independent value. Students may not modify case facts, but may interpret, supplement or challenge them as they see fit. 5. There is never “enough” information in cases. The cases are real and you may supplement your knowledge by library or other research. It is difficult, though not impossible, to receive an “A” grade without demonstrating outside research. Each case has a bibliography at the end. If there is still some piece of information that is both missing and critical, you may assume some “logical” fact (provide me with a footnote or some other hint to your analysis of why this missing information is important and why your assumption is “logical”). Present your case analysis in the following format: a. At the top of the paper indicate your choices of individual and point in time. b. “Problem finding” is frequently the most difficult part of the analysis. It is a skill that takes intellect, creativity, effort and practice. State the problem faced by this individual succinctly (one clear sentence if possible). This statement should reveal the issue you see as the focus of your analysis and should necessitate a decision on the part of your chosen individual. This sentence is often the last one to be written in final form, since your views will change as you go deeper into the analysis. A provisional statement will be enough to get you started, since it is likely to be revised more than once. The remainder of this paragraph will explain why this is such a problem for this individual. This explanation might include such items as individual strengths/weaknesses, constraints (time, power, information), opportunities, complicating factors and how they are important to understanding the problem. “Problem finding” may be the most difficult part of the analysis, since it should not be stated to obviate any particular choice among alternatives. You may find particular difficulty when the “problem” is clear to you, but is unlikely even to be sensed by the individual you have selected. c. Indicate the goals and objectives this person has that are directly related to the problem above. “Maximizing profits” is probably too general to help in a specific instance. Be as precise as possible. Individuals are not limited to “worthy” motives. Organize this section around 2 or 3 major goals; otherwise confusion and conflict will result from a “laundry list” of desirable outcomes. These goals and objectives should form the foundation for your analysis of the alternatives. d. Devise the means by which this individual can measure the attainment (or progress toward achieving) these goals. If you cannot measure goal attainment, then perhaps you ought to reword your goals. e. Order the major alternative solutions-rejected solutions first. There should be at most 2 or 3 alternatives. i. For each rejected solution, indicate first, the reasons why the individual considered this alternative at all. What are the positive aspects of this course of action? (Relate to the goals and lbjectives section). [If there are no positive aspects, then this is not a viable alternative and should not be included here (any fictitious and unrealistic alternatives will be termed “straw man” choices). If an “alternative” is not truly viable and realistic, then put its rejection into the problem paragraph as a constraint or totally eliminate it.] Then for each rejected alternative, you should indicate why it is rejected (based on goals and objectives). ii. For the chosen alternative, indicate first, any drawbacks this individual sees in following this path. Then indicate why this is the best alternative. This is often a lengthy analysis and would include some assessment of the uncertainties involved. f. Indicate any specific actions this individual will take to implement and enforce this decision. Be as specific as possible. The analysis does not end merely by making a choice among alternatives. If an action is common to all alternatives, it probably belongs in the implementation section. 7. When finished, the case analysis should “hang together” in the sense that the chosen alternative should have some chance of solving the problem and achieving the stated goals. You will frequently find that you will have to reevaluate your statement of problems and goals continuously as the analysis proceeds.




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