FDA’s Effectiveness in protecting non-US humans

Is the FDA effective in protecting the safety of human subjects?


Subjects Background — This is the introduction and will include key issues — broadly defined, where’s the beef?
II. Problems/Obstacles — This is the argument section — who cares? why? There are lots of ways to handle this:
1. Break down key issues one at a time in the same order as you addressed in background, give the pro side in one paragraph followed by the con side in the next paragraph; follow this format for each of the key issues.
2. Break down key issues one at a time as above, introduce arguments with pro followed by con (some say, others say); end each section with strong pro statement;
3. Key issues as above, present entire con argument (or pro argument) for ALL key issues, THEN, switch sides and argue the opposite perspective. Some folks like to begin with pro and end with con so that they can directly rebut in solutions section (next). Others like to start with con, transition to pro and then continue to build argument in solutions.
III. Solutions — This is the counter-argument place. Propose solutions in light of objections — yeah, but…. Again address in same thematic order as key issues and problems/obstacles.
IV. Conclusion — briefly summarize your main points, reiterate thesis and craft a send-off message.

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