Regulation of tobacco-including advertising and promotion

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Reference no: EM133810897

Question

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. The course paper must be on a regulatory affairs topic. Examples of 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 FD&C Act (covered in the course) and applying it to arelevant topic to the industry today.

2. Identify a Warning letter from the FDA website and explain how the manufacturer violated the FD&C Act and what steps need be taken to prevent further violation or whatother enforcement actions may the FDA bring.

Reference no: EM133810897

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