Actual - Writing and Speaking

Fan fiction is fiction written by people who enjoy a film, novel, or other media work, using the characters and situations developed in it to create new plots in which to use these characters.

Fan fiction has been goi

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ng on for decades, centuries, I’m sure even millenniums. It could be noted as far back as the ancient Egyptians. For example, the ancient Egyptians lauded many gods in their society and even wrote literature on these g

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ods, such as Horis and Isis. When the Egyptians came in contact with the Greeks many centuries later, the Greeks picked up some of the Egyptian gods as their own and wrote stories on them. When the Romans came into th

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e picture, they picked up some of the Greek gods as their own and wrote new plots for them. Up to this day many of the mythological gods people are aware of are usually seen as Roman or Greek myths and fiction. Some p

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

eople don’t even think to link them back to Egypt. Of course this is thousands of years ago when copyright didn’t exist and the population of the world was a lot smaller. There wasn’t any technology like the Internet.

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Most literature creators at that time probably did not worry too much about infringement. I mean, it’s not like the Egyptians could have rode to Greece in their chariots and accuse them of violating copyright laws.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

However, even back then people faced severe punishment for changing or misrepresenting a story or literature renowned in their society, and the law was not kind on what we call fan fiction today.

We are in the twenty-

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

first century; technology is at an all time high and increasing. Fans can get access to almost any media work published in an instant. And, the copyright laws of course still favor the originator. Okay, what about fa

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nfiction in the twenty first century? The simple answer is it is still frowned upon. Then, is there any spot for fan fiction publishing? Of course there is. What I believe is that fanfiction keeps the world of literat

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ure revolving. I’ve observed that this is especially true for popular published literature. Usually when a book hits the shelf or a story is told, may even be on historical facts, despite the popularity and liking of

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

the story, everyone is not satisfied. Many fans may think to themselves, “what if it happened this way?” Some fans even go out and create a fiction based on how they think the story should have happened. Some of thes

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e fans share their version with others in chat groups, message boards and so on. The effect of these fans actions? We now have more text and a wider audience.

If fan fiction makes the world of storytelling go round sh

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ould fanfiction be allowed to broaden audiences and possibly allow economic growth due to the purchasing of the fictions by the curious minded? Or maybe the stories should be left as was created. But what if the story

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

is unfinished? Should the curiosity of the audience be quenched by imaginative family members, friends, hired publishers or most of all, fans? I believe this is up to the originator to decide. If the originator does

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

n’t want any changes to his story then the fans have to respect that.

Due to infringement many creators are afraid to tamper with any original copyright work. Nobody wants to get in trouble for plagiarism. What creat

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ors have to know is that fan fiction is usually frowned upon when it misrepresents the original character and mostly when the creator tries to commercialize it. You can think of it this way, it is like taking money fro

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

m your boss. Most publishers are cool when fan fiction is in the closet, meaning hidden, not commercialized and intended for your group of people or family like setting. Doing this is just like telling a story to your

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

family or friends.

Fan fiction creators must remember that the only reason your fan fiction exists is because of the originator of the fiction or story. Fan fictions have an audience because the original had an audie

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

nce. As mentioned before, think of it like working for a boss. People are usually at their job because their boss hired them. I’m saying this because writing fanfiction is a good way to get noticed as a writer or cre

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ator. Some people make a living off writing fanfiction. This is alright as long as fan fiction creators respect the requests of the original author or publisher and not try to commercialize it.

Copyright 2006 Gideon

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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