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.

 

Sample Solution

digitalisation of consumer books. Exploring areas in chorological order of where the publishing industry initially began, how it has changed over time and where it is now. The differences and pros and cons of traditional publishing and self-publishing. Then discuss what digital publishing is and how it began. Finally compare the two types of publishing and challenges that consumer books are currently facing and their effects.

What we have come to know and love as the ‘traditional’ book is only about 500 years old, but the idea for a book can be traced to Egyptian and Greek times. This was well over 5000 years ago, where the Greeks stored papyrus rolls (papers used for writing) in their big libraries as a way to deliver ideas to the public in contrast to their previous oral traditions. After the introduction of the printing press by Johann Gutenberg, mid fifteenth century, allowed religious texts to be printed on a mass scale. ‘The Gutenberg Bible became the first major book to be published in 1455.’ (Gosparkpress.com, 2019). This became the catalyst to what become ‘the first ever publishing industry as printing houses started opening in all areas around Europe.’ (Dreyfuss, 2016) From here the industry kept developing and eventually became what it is today. Books now hold much more information than only religious texts or information about history. There are three main sectors that make up the book publishing industry: consumer books, schoolbooks and academic books. Consumer books have been the driving force of the publishing in the past, as readers can relate to context on an extremely personal level; especially if the themes and context of a book whether it be fiction or non-fiction has some correlation to readers’ own lives. According to Greco, books are seen as ‘special’ with complex ideas. (Greco, Milliot and Wharton, 2014)

There are two different ways of publishing, the first is the traditional way which is where an author submits their book to a publishing house where they decide whether to publish it or not. From there a contract is drawn up and finally the publishers get the book ready to market. This process includes the editing, designing and formatting of the book. Before the rise of the internet it was the only way for authors to publish their books on a global scale. The second way of publishing, that has become more common in recent years, is self-publishing. This process differs as the author publishes their work themselves as opposed to seeking out a publishing house for any approval or help. The author is the publisher, they are themselves are in charge of the entire editing and design process after which they can also market their own book. Both these processes each have their individual benefits and setbacks.

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