regulatory AffairsYou are asked to apply your learnings throughout the course to develop a comprehensiveregulatory plan for a drug you make-up. I will belooking to ensure you apply critical thinking asyou describe the development stages, regulatoryprocesses, regulations,procedures, applicableguidance documents, necessary meetings and relevant challenges your product will face. Youshould begin at the pre-clinical phase; discussthe steps and activities through to the submissionof the New Drug Application and plans for beyond.With regard to the drug you invent, please providethe therapeutic area as well as the indicationyou are developing the product for. It is not required to come up with a chemical formulation foryour product, but you are welcome to if you would like.I recommend that once you review the details for this assignment you begin developing yourregulatory plan by adding to it and revising it weekby week. A table of contents slide should beincluded and is also a good way for you to organize your presentation. The last slide of yourpresentation should include all your references; you do not need to include references on each ofyour slides.Please do not wait until the last week to work on this. I recommend building it over time. If youhave any questions please do not hesitate to postyour question in the ‘Ask the Instructor’ forumor email me directly.

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?