Just Answers - Writing and Speaking

"The men who try to do something and fail are infinitely better than those who try to do nothing and succeed." Lloyd Jones

I think the one thing that bothers me about

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

people of all shapes and sizes, of all races and creeds, of all types of occupations or lack thereof, is when they just give up or don’t try.

When I was a kid the words, “I can

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

Examples of combination products may in

t” were banned from our household. Any time someone in our household forgot and uttered those words, the rest of us would start singing a song. “I’ll never, ever say I can’t; I’l

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

always say I’ll try.” That, my friends, is the key to succeeding at writing or at anything in life. You just have to try.

Over the years, I’ve heard many new writers lament abo

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

t not being able to get published. Becoming a published writer is much like finding that first good job. Many jobs require experience, but how does one get experience if one cann

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

Combination pro

ot get a job? The answer to that is often to take lessor jobs and prove that you can handle them before applying for better jobs.

The same can be said about becoming a publish

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

d author. Yes, there are many publications that only seek the work of already published writers. If those publications are your ultimate goal, you will have to find ways to prove

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

that you have been published elsewhere.

Finding places to be published is not a difficult task, although it may require research and your time.

1) Are you an “expert” at someth

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

ng – video games, bowling, crafts? If so, find an online publication that seeks writings of those who are adept at these activities. Online publications may or not pay, and if th

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

ey do reward writers, it might be just $5 to $20. There are some writers who will tell you to never write for free. Sometimes, though, writing for free is the only way you can

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

rove to larger and better paying publications that you have been published somewhere. The decision about whether or not to write for free is ultimately yours and yours alone. Jus

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

Following aspects would a

remember that having your work appear online – even after it is archived – gives you a URL that you can place in your writer’s credits.

2) Purchase the latest Writer’s Marke

dd to the challenges in developing combination products:

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

book, or borrow it from your library to discover more outlets for your work. Focus on lower paying markets first, since it is easier for new writers to break into those mark

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

ets.

3) Subscribe to writer’s magazines or find out if your library subscribes to them and plan on spending some time in the reading room. Often times you will find newer market

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

there.

4) Enter contests – found online or in writer’s magazines. Often times, the winners of those contests are rewarded with publication as well as cash prizes. (Just be war

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

of those contests requiring hefty entry fees!)

5) Do join a writer’s group in your locale or an online group where you can receive in-depth critiques of your work. Sometimes ju

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

Professional from academic institutions, pharmaceutical industries, health care indust

t changing a word or two in one’s writing makes all the difference in the world about whether or not it is fit for print or publication.

6) If the only thing you want to do is t

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

o publish a book, that may be a more daunting task. Do search for just the right publisher(s) – in Writer’s Market and writer’s magazines. Do not get discouraged, though.

.

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

ven some of today’s best-selling authors had to begin by self-publishing.

There is still almost a full year ahead of you. Will this be the year that you collect writer’s credits

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

Companies that provide selfless information through particip

Will this be the year that you see your work published? It can be, but only if you decide to put the work into getting published.

Remember, the words, "I can't" are not allowed

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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