Write You - Writing and Speaking

In order to attain success as a writer of special feature articles, you must possess at least four qualifications:

(1) ability to find subjects that will interest the average man and woman, and to see the picturesque, romantic, and significant phases of

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

these subjects;

(2) a sympathetic understanding of the lives and interests of the persons about whom and for whom he writes;

(3) thoroughness and accuracy in gathering material;

(4) skill to portray and to explain clearly, accurately, and attractiv

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

Examples of combination products may in

ly.

The much vaunted sense of news values commonly called a "nose for news," whether innate or acquired, is a prime requisite. Like the newspaper reporter, the writer of special articles must be able to recognize what at a given moment will interest the

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

average reader. Like the reporter, also, you must know how much it will interest him. An alert, responsive attitude of mind toward everything that is going on in the world, and especially in that part of the world immediately around you, will reveal a h

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

st of subjects. By reading newspapers, magazines, and books, as well as by intercourse with persons of various classes, a writer keeps in contact with what people are thinking and talking about, in the world at large and in his own community. In this way

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

Combination pro

you find subjects and also learn how to connect you subjects with events and movements of interest the country over.

Not only should you be quick to recognize a good subject; you must be able to see the attractive and significant aspects of it. You mus

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

understand which of its phases touch most closely the life and the interests of the average person for whom he is writing. He must look at things from "the other fellow's" point of view. A sympathetic insight into the lives of your readers is necessar

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

y for every writer who hopes to quicken his subject with vital interest.

The alert mental attitude that constantly focuses the writer's attention on the men and women around him has been called "human curiosity," which Arnold Bennett says "counts among

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

he highest social virtues (as indifference counts among the basest defects), because it leads to the disclosure of the causes of character and temperament and thereby to a better understanding of the springs of human conduct". The importance of curiosit

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

y and of a keen sense of wonder has been emphasized as follows by Mr. John M. Siddall, editor of the American Magazine, who directed his advice to college students interested in the opportunities afforded by writing as a profession:

A journalist or writ

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

r must have consuming curiosity about other human beings - the most intense interest in their doings and motives and thoughts. It comes pretty near being the truth to say that a great journalist is a super-gossip - not about trivial things but about impo

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

Following aspects would a

tant things. Unless you have a ceaseless desire to learn what is going on in the heads of others, you won't be much of a journalist - for how can you write about others unless you know about others?

In journalism, men are needed who have a natural sense

dd to the challenges in developing combination products:

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

of wonder. . . . You must wonder at man's achievements, at man's stupidity, at his honesty, crookedness, courage, cowardice - at everything that is remarkable about him wherever and whenever it appears. If you haven't this sense of wonder, you will neve

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

write a novel or become a great reporter, because you simply won't see anything to write about. Men will be doing amazing things under your very eyes - and you won't even know it.

Ability to investigate a subject thoroughly, and to gather material accu

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

rately, is absolutely necessary for any writer who aims to do acceptable work. Careless, inaccurate writers are the bane of the magazine editor's life. Whenever mistakes appear in an article, readers are sure to write to the editor calling his attention

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

o them. Moreover, the discovery of incorrect statements impairs the confidence of readers in the magazine. If there is reason to doubt the correctness of any data in an article, the editor takes pains to check over the facts carefully before publication.

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

Professional from academic institutions, pharmaceutical industries, health care indust

He is not inclined to accept work a second time from a writer who has once proved unreliable.

To interpret correctly the essential significance of data is as important as to record them accurately. Readers want to know the meaning of facts and figures,

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

and it is the writer's mission to bring out this meaning. A sympathetic understanding of the persons who figure in your article is essential, not only to portray them accurately, but to give his story the necessary "human interest". To observe accuratel

.

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

y, to feel keenly, and to interpret sympathetically and correctly whatever you undertake to write about, should be your constant aim as a writer.

Ability to write well enough to make the average person see as clearly, feel as keenly, and understand as w

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

Companies that provide selfless information through particip

ll as he does himself the persons and things that he is portraying and explaining, is obviously the sine qua non of success. Ease, fluency, and originality of diction, either natural or acquired, the writer must possess if his work is to have distinction

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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