Advice Pool - Business

I like to (quickly) thank those who give me good service, and (gently)

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

critique those who don’t.

Here’s an easy and effective way to do it.

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

Examples of combination products may in

designed and then printed 500,000 laminated, full-color, wallet-sized

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

cards that say: ‘GOOD JOB! Nice work! Well done! Keep it up!’ on one si

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

e, and ‘CHEER UP! A smile costs you nothing, but brightens up everythin

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

Combination pro

g!’ on the other.

There’s a big, bright yellow sun on the ‘Good Job!’

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

ide, and a smaller timid sun peeking out from behind dark clouds on the

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

‘Cheer Up!’ side.

I took these cards on a recent trip and gave them t

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

immigration officers, taxi drivers, airline cabin crew, room service s

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

taff and others. The impact was amazing! Eyes lit up and smiles appeare

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

. Even those who did not speak English got the happy message right away

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

Following aspects would a

.

Leaving one hotel, I asked the porter, ‘Have I given you a “Good Job

dd to the challenges in developing combination products:

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

” card?’ He pulled out his wallet quickly. Opening it, he showed me a p

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

hotograph of his wife and child, with a bright, sunny ‘Good Job!’ card

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

ight beside.

Key Learning Point

People everywhere appreciate recognit

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

ion. Find a way to acknowledge those who serve you well, and raise the

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

Professional from academic institutions, pharmaceutical industries, health care indust

pirits of those who need your help. You don’t have to provide therapy,

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

give money or write long letters. A simple ‘Good Job!’ or ‘Cheer Up!’ c

.

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

rd will do.

Action Steps

Visit our website product section to see the

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

Companies that provide selfless information through particip

‘Good Job!’ and ‘Cheer Up!’ cards. Order yours now – then pass them on

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/14893/advicepool-Nice-Work-Well-Done-Keep-It-Up.html">Nice Work! Well Done! Keep It Up!</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/14893/advicepool-Nice-Work-Well-Done-Keep-It-Up.html]Nice Work! Well Done! Keep It Up![/url]

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