Write You - Writing and Speaking

Last year, and before the death of a loved one, a literary agent agreed to assess the merit of a copyrigh

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

ted novel I wrote. Then again, maybe I should change the name of this story to: "Beware of Con Artists."

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

Examples of combination products may in

The agency has a website together with loads of promotional material filled with so many satisfied writer

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

s and want-to-be authors, and it's owned by a publishing company. Well, how lucky can I get? I sent the e

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

tire story to them as fast as I could.

About a week later I received a call from the secretary of the ow

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

Combination pro

er of that publishing group. The owner would call me at a mutually agreeable time within the following we

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

ek. That's fine with me, and a few days later I received the call.

I was told that I wrote a great story

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

but it was too long and I needed a third voice. No problem for me. I bought a few of the books she wrote

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

just to stay on friendly terms in spite of the fact that she wanted me to pay one of her writers $28,000

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

o rewrite my story. If someone else wrote my story it wouldn't be mine. Right? Then again, according to h

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

r, some people earn six figure incomes using that method.

As the old saying goes: "If you give people en

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

Following aspects would a

ough rope sooner or later they'll hang themselves." I told her that I'd have to mortgage my house, and wi

dd to the challenges in developing combination products:

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

hout a guarantee of publication, I couldn't do such a risky thing. No problem, for $9,800 she would spend

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

three days in a hotel room with me and together we'll put the story together. Who thinks about writing w

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

en a beautiful woman is willing to share three days in a luxury hotel? Not me. I love women.

I said that

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

I'd think about it, and she asked me to rewrite the first chapter using her suggestions. I did it her way

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

Professional from academic institutions, pharmaceutical industries, health care indust

even though I didn't much care for the end result. To make a long story short, she called again and told

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

me that my original version was better, and again pitched her writer deal. I told her that I'd work with

.

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

any of her editors if she agreed to publish my story. It was her deal or no deal.

I asked a few question

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

Companies that provide selfless information through particip

and the answers I got clearly told me that she didn't read my story. I might be dumb, but I'm not stupid

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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This article gives ideas of what to do once you have room to spare in your office. After taking part in document scanning you will need to get those filing cabinets out of the way and make room for a new office. What will you do with the opportunity?

There are so many kinds of work that needs to be done and you are doing one of those jobs right now – unless you are one of those two and a half million that have been laid off during the past 3 years. The press continues to blame China and India for stealing away all these forms of employment, but they don’t have it right...

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