E-Articles - Writing and Speaking

Writing is my chosen career, but it can be difficult at times. As a health writer I know I must have r

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

eliable resources. I spend hours on the Internet, play telephone tag with people I want to interview,

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

Examples of combination products may in

nd read health information constantly. My approach to writing is simple: The more I write the better I

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

will become.

I have been a freelance nonfiction writer for 28 years. These years have taught me patie

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

ce. If I get stuck on something I know I will get unstuck. It's just a matter of time. Years of writ

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

Combination pro

ng have taught me how to pace myself and I am grateful for this skill. I have also learned how to roll

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

with the punches.

When I first started writing every word was important -- cast in stone. If an edito

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

wanted to change a word or phrase I became defensive. Thank goodness I have gotten over that. Now I

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

ocus on the quality of the product. I work hard, I enjoy working hard, and I enjoy every aspect of wri

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

ing, even revisions.

Still, like every writer I feel down if I receive a rejection letter or comment.

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

What do I do? I review my writing affirmations. These affirmations grew from thoughts in my mind to t

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

Following aspects would a

houghts on paper. Coming up with these affirmations helped me to learn more about myself and my work.

dd to the challenges in developing combination products:

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

1. I will use the word skills that were given to me.

2. I will write books and articles that help othe

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

s.

3. I will work hard to distill information and make it readable.

4. I will reveal myself in everyt

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

ing I write.

5. I will learn and grow from reviews.

6. I will listen carefully to readers' comments a

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

d suggestions.

7. I will be patient with myself.

8. I will trust my writing instincts.

9. I will let

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

Professional from academic institutions, pharmaceutical industries, health care indust

creativeness lead me to new projects.

10. I will find joy in everything I write.

These are my writing

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

affirmations. What are yours? Making a list of writing affirmations can energize you, keep you going,

.

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

and help you rediscover your career. Though there are exceptions, most writers do not write for the mo

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

Companies that provide selfless information through particip

ey, we write because we love doing it. We wouldn't do anything else.

Copyright 2006 by Harriet Hodgso

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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There are various reliable training centers on the World Wide Web that allow business owners to actively participate to various professional Business Improvement Programs. Such professional training programs account for a wide range of features

In your opinion, does lying ever have a place in business? And if you answer with an emphatic 'No!', are you telling the truth?

While Motivation may seem like a pie in the sky ideal, it does have a real effect on your bottom line which should not be overlooked.

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