Others - Writing and Speaking

Wanting to be a novelist is a lot easier than actually becoming one. Planning and writing a novel takes months, or for some people

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

, years.

When your manuscript makes it to an editor's desk, you feel that you're almost at the finish line and envision bounding

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

Examples of combination products may in

cross it. You endure the wait but then your manuscript comes back with a rejection letter. Disappointed, you read the letter sever

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

al times, determined to understand what the editor didn't like about your book.

Here's where the writer's hope, dreams and ambiti

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

n get in the way of reality. One of my writer friends once said about rejection letters that there are a million ways to say no an

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

Combination pro

only one to say yes.

Any time an editor rejects your manuscript, it means she didn't like it well enough to buy. It's not her jo

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

b to critique your work. An editor's job is to find manuscripts she knows the company can sell. Editors are nice people. Even if t

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

ey don't want to recommend your novel, they don't set out to hurt your feelings or be cruel. They recognize the time and work you

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

have put into the novel and perhaps even your talent for a promising future. They mention general areas to be helpful. They don't

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

uggest specific changes because they may not be sure what will make the story work.

That's where the million ways to say no come

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

n. Here are a few examples of how an editor may let you down gently but still indicate what's wrong with your novel.

"Your story

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

Following aspects would a

idea is intriguing" may mean she liked the basic idea, but you didn't develop the plot well enough.

"Your protagonist isn't invol

dd to the challenges in developing combination products:

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

ed enough" can mean the protagonist didn't move the action forward and solve the story problem.

"The story doesn't come to a sati

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

sfying conclusion" may mean the action didn't build suspense and dramatic tension all the way through to make a strong finish poss

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

ble.

These few examples give you an idea of how an editor can indicate weak spots without going into details. She's not implying

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

few revisions will make the novel salable. She’s not saying make these changes and send the manuscript to her again. If she wants

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

Professional from academic institutions, pharmaceutical industries, health care indust

you to do that, she will say so.

Pay attention to the comments, but don't revise or rewrite your novel on the basis of one criti

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

ue by an editor, agent or other reader. If several editors comment on the same aspect of your work, it may be time to revise or re

.

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

write. If you have any doubts about what changes to make or how to best do them, you may want to consider getting an independent p

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

Companies that provide selfless information through particip

ofessional opinion so your next letter from an editor is that one way to say yes: a contract to publish your novel.

Copyright 200

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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I love being able to choose where I work - at home, in the local cafe, on a plane, at the airport waiting for the plane, on holiday, where ever happens to suit me today. All I need is my laptop - well actually half the time I don't even need that. If I am writing an article or Blog post I can just take a notebook and pencil, stuff it in my pocket and go sit on the beach to write.

Equity Indexed Annuities (EIAs) have become the hot product of late. I believe you can easily find other alternatives that will bring a better return, without locking up your money or levying hefty surrender penalties. I'll discuss these alternatives in the next two articles. But first, you should understand two things: your purpose for investing and how EIAs work.

Just because you have bought a lemon car or RV you don't have to be stuck with it.

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