Social Articles - Writing and Speaking

Many of us have experiences, observations and things we want to say and one way to do this is through writing. Others ar

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

e of a creative nature and well we cannot turn off our minds and it makes sense to become a writer. Unfortunately, writi

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

Examples of combination products may in

ng is a skill that must be learned. Many of us have a predisposition for writing and perhaps had some success as teens,

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

ut did not pursue that venue as we grew up and chose majors in college or careers out in the world. If you are at the po

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

int where you would like to become a writer then you maybe pleasantly surprised that it is possible to teach yourself ho

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

Combination pro

to write.

There are an abundance of books, online courses and helpful writing consultants to help get you started. All

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

you need to do is to set becoming a writer as your goal and then get busy writing and practicing until you become profi

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

cient. What should you start writing about you ask? Well anything that comes to mind is the answer some professional wri

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

ers give to novices. It is important to get use to writing a lot so that you can produce the word counts needed to compl

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

ete your writing projects, essays, short stories, articles or novels on a timely basis. The more you write the better yo

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

will get provided you stick to the basics and do not teach yourself bad habits.

How do I know this? Well, I have becom

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

Following aspects would a

e the most prolific online article writer in the history of the Internet and written over 10,100 articles now. This is i

dd to the challenges in developing combination products:

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

nteresting in that I am not a writer, or at least never considered myself one. I accomplished writing the 10,000 article

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

in about 20-months and one might say how is that possible, as even newspaper reporters might take over ten years or mor

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

e and still come up far short of such an a number.

Indeed, I committed myself to writing a minimum of 8,000 words per d

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

y and on most days wrote over 10,000 words and in some days as much a 18,000 words in a single day. Again I am not a wri

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

Professional from academic institutions, pharmaceutical industries, health care indust

ter. This is what has prompted me to write this eBook as other article authors have asked me; How did you do that? You m

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

ust be a machine? Surely you have people helping you?

The truth is I am going to tell you how I did it, so you can too

.

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

nd No I am not a machine, nor did I have any help, although at times, I sure could have used some. I appreciate you read

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

Companies that provide selfless information through particip

ing all my articles on writing and How to Become a Writer. Perhaps this article is of interest to propel thought in 2007

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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