Regulatory Strategy Recommendation
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.
INFO; A new small molecule drug product consisting of only 1 active pharmaceutical ingredient
Minimal preclinical studies; no Good Laboratory Practice toxicology studies have been performed
Initial indication company is seeking: for the treatment of obesity
Patient population: adults with a BMI >30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes)
Dosage: 1 tablet once daily
The question you are trying to answer for the Pretend company is whether they should advance the Obesity Drug to clinical development — and whether to proceed in the US or EU.
I have provided the Regulatory Intelligence on what other investigational or approved drugs are available, the regulatory pathway, what preclinical and clinical studies will need to be performed, etc.
To answer the question of whether there could be an abbreviated approval pathway, you need to research what other companies are doing, or have done, and looking at the guidance documents, whether you could do anything different. Your commercial team will want to know opportunities for accelerated approval, breakthrough therapy designation, orphan drug status, etc. This may not be possible, but you do need to do the research to answer the question.
Mostly, all the steps to get a new drug to market are on this page
There are many other references listed in the attachment. Please note references as they are used from either the provided info or other sources in AMA Format.
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