regulatory affairs

Topic: regulatory affairs

Paper details:

Question 1: use the case labeled Pearson v. Shalala

This case is about qualified health claims on dietary supplement labels. The supplement manufacturers’ health claims were rejected by the FDA with little to no explanation. The manufacturer sued. The court sided with the manufacturer and sent the case back to the lower court and to the FDA to give some meaning to the term “significant scientific agreement.” Do you agree or disagree with the court’s opinion that the FDA could not just deny the claims? Why or why not? How could you define the phrase, “significant scientific agreement”?

Question 2: use the case FDA v. Brown and Williamson

In this case, the FDA tried to assert jurisdiction over cigarettes. Obviously the Supreme Court did not agree, but what do you think of the FDA’s arguments for asserting jurisdiction? Do you believe that the arguments are valid? Do you agree with the Court’s decision and analysis? Why or why not?

Question 3: use case study Sottera

Which do you think is more convincing, the Opinion of the Court or the concurring opinion? Why?

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