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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.

Sample Solution

ifferent Typographic rules before deciding to break them may lead to new perspectives. I find it helpful that the author collated points from different articles written by people who are knowledgeable on the subject as it gives the reader different viewpoints and things to consider when it comes to Typography, which I believe is important as Typography exists for many different reasons. In another article entitled Modern typography: an essay in critical history written by Robin Kinross and published in 2010, the author talks about how printing is a powerful tool to be able to spread knowledge and is fundamental in the development of the modern world, thus paving the way for modernization.6 The article focuses on content as the author elaborates on print production and content delivery and talks less about how content is designed and laid out. The author also believes that Modern or stunt Typography may be baseless in terms of history as the concept mainly focuses on aesthetics (Kinross,2010).7 In addition to this, Kinross debunks the idea that all typography is book typography.8 Furthermore, the author argues that understanding design, or the concept of it, has more to do with looking at the creative processes as opposed to focusing on output. The author points at how people may think of the product as the design, when in fact, the design is the process (Kinross, 2010).9 As Kinross relates Typography to Print Production and focuses on the purposes of both, this may suggest that similar to Muggeridge, he also believes that Typography is mainly about function. Overall, I agree that printing has opened up opportunities for learning, which may have helped with modernization, and that paying close attention to how text is designed and laid out is crucial. Kinross emphasized the significance of printing and how printing paved the way for learning and establishing history, which I believe is important to note as gaining knowledge may be the primary purpose of ensuring that a piece of content is translated clearly through well-laid out and well-defined typography. I also agree that design is understood better, especially by non-designers, in terms of processes as opposed to just looking at a final product. To sum up, the article presented different poin
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