Write You - Writing and Speaking

So you want to be a writer? How can you be a good writer? It w

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

ould be difficult to define a good writer with just one defini

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

Examples of combination products may in

tion.

Writing is an art as well as a science. Writing is an a

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

rt since it has various styles to it and it is a science as yo

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

u would use different techniques to write it.

Good writing ho

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

Combination pro

wever has much more to it than just the common techniques used

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

. [It depends on who your target audience is and whether you k

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

now your audience well]

The parameters for a good writer depe

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

nd on the audience who is going to read it.

For instance, the

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

differences between the style content writers use and the sty

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

le full-time is that the content-writers mostly use first and

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

Following aspects would a

second person; whereas a writer for a newspaper would use an o

dd to the challenges in developing combination products:

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

bjective tone (third-person reporting). The language used is a

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

lso different for different media of communication.

The gener

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

al yardsticks to determine whether one is a good writer are to

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

check whether his/her article has a good flow, eye-catching c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ontent and the language. The sentence structure, grammar, idea

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

s and the form used are some of the other factors that play an

.

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

important role in determining whether one is a good writer.

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

Companies that provide selfless information through particip

However, there is no one way to find out who a good writer is.

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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