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I stayed in an Orlando hotel suite for ten days. Breakfast was available in the con

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

cierge lounge each morning: oatmeal, bread with butter and jelly and an assortment

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

Examples of combination products may in

f sliced melon.

Each morning I looked for a banana to top off my oatmeal. Sliced m

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

lon, yes. But banana, no.

On the third day I spoke to the staff in the lounge.

‘Y

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

ou want a banana?’ she asked. ‘No problem. I’ll have one for you tomorrow.’

The ne

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

Combination pro

t morning, and every morning thereafter, she brought me a banana, usually keeping i

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

hidden until I appeared. Occasionally another guest would see my special banana an

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

d look for another. But there were no more bananas. Only sliced melon.

Days later,

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

I asked the Food & Beverage Manager, ‘Why don’t you provide bananas at breakfast? O

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

her guests seem jealous of my bananas – and I notice the sliced melon is often sent

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

back to the kitchen untouched.’

He replied, ‘If we provide bananas, everyone would

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

Following aspects would a

take one, or even two! That is more fruit than we want to give out in the morning.

dd to the challenges in developing combination products:

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

With the sliced melon, we know how much fruit we are allocating to the breakfast. E

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

en if it is not eaten, we have control over our food costs.’

Our room rate on the

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

Concierge Floor was more than $300 per night. Bananas cost about sixteen cents each

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

Key Learning Point
--------------------------------------------------

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

Professional from academic institutions, pharmaceutical industries, health care indust

-----------------------------

If your staff have to bend the rules to ke

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

ep your customers happy, it may be your rules that need revising.

Action Ste

.

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

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

Companies that provide selfless information through particip

----

Find a rule that gets bent regularly by your staff. Change the rule

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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