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To tell you the truth (and about 53% of this article is true),

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

I don’t know where I heard this story about Mark Twain. But I

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

Examples of combination products may in

ve heard it enough times to verify that it’s either (a) at lea

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

t half true, or (b) a credible lie.

Anyway, it’s seems that i

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

the early 1850’s Twain – then known as Samuel Clemens – found

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

Combination pro

himself in San Francisco without a job. The reason he was ther

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

e, I believe, had something to do with the Gold Rush.

Twain l

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

ved the town, and wanted to stay. But to do so he had to find

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

job. Since he’d worked on a newspaper before, he applied at a

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

big publication there.

No thanks, the editor said. We don’t n

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

ed any writers right now. And even if we did, we don’t have mo

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

Following aspects would a

ney in the budget to pay them.

Twain countered with an amazin

dd to the challenges in developing combination products:

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

offer. What if he agreed to work for free? I’ll write for you

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

Twain said. You publish my work, and if people like what I wr

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

te, maybe you’ll hire me.

You can guess the rest of this repo

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

t. The editor loved Twain’s work, hired him, and Twain’s caree

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

Professional from academic institutions, pharmaceutical industries, health care indust

r continued to build. But what if he’d simply walked out the d

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

or that day?

The moral of this story: Free is pretty hard to

.

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

efuse. Next time you have trouble winning a client, how about

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

Companies that provide selfless information through particip

ffering to do a project for free, just to show what you can do

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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