The Regulatory Intelligence Report developed by your team (attached as a reference) will provide the background and starting information to develop this Regulatory Strategy Report.
This report will include your recommended approach for filling new drug applications, a projected drug submissions timeline, and anticipated regulatory issues for the development of the fictional “New Product” for Obesity.
Use the attached template “Regulatory Strategy Recommendation template” to develop and document your regulatory strategy and recommendation.
The research has been completed and attached.
Using the template, I need to compose my recommendation for how this small (pretend) company should approach getting their new Obesity drug approved by the FDA.
Here are some other facts about our pretend company and pretend drug.