Pharmaceutical and Medical Device Law: COURSE OUTLINE

Course Paper Guidelines

Pharmaceutical and Medical Device Law: RGA6203

As a part of the course you will be required to submit a course paper to discuss and evaluate one of the topics covered in the course. Example topics include but are not limited to:

1. The regulation of tobacco, including advertising and promotion 2. Should direct to consumer advertising of drugs and/or devices be banned? 3. Software as a device 4. Off-Label use of prescription drugs

This is not an exhaustive list. You are welcome to write about a topic based on a Discussion Board conversation or a topic that interests you taken from the topics covered in the course.

Examples on how to approach the paper include:

1. Chose a specific section of the FDCA (covered in the course) and applying it to a relevant topic to the industry today.

2. Identify a Warning letter from the FDA website and explain how the manufacturer violated the FDCA and what steps need be taken to prevent further violation or what other enforcement actions may the FDA bring in this case.

*I am also open to other suggestions and original ideas.

The requirements for the paper are as follows:

Use a minimum of 3 cases discussed in the class or current cases being reviewed by the courts and describe how a specific decision applies to your chosen topic. The course paper is to be a minimum 10 pages in length double-spaced (not including citations), font size 12, 1 inch margins.

Organization of the Paper:

a. Introduction - State your topic and the purpose of your paper clearly. What is the main reason you are writing the paper? Explain briefly the major points you plan to cover in your paper and why readers should be interested in your topic. b. Body (Facts, Analysis and Discussion) - Present the findings about your topic and supporting arguments. Cases would be included in this section.

c. Conclusion - Restate the reason you are writing the paper. Summarize your findings and arguments. Explain why you have come to this particular conclusion.

If you have any question about the Course Paper please email me.

Assignments related to the Course Paper

Course Paper Topic: A short paragraph describing the topic you have chosen. You can provide more than one topic if you are still deciding. Due: Week 8

Course Paper Outline: One page outline of your paper including main ideas. Due: Week 10

Course Paper Due: Due Week 12