Main Subject - Business

I accompanied a visiting friend from my apartment in Singapore to a taxi waiting d

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

ownstairs.

He climbed into the back seat and promptly sat on a wallet left behind

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

Examples of combination products may in

by the previous passenger.

My friend looked inside the wallet and found money, c

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

redit cards and personal identification. I suggested taking the wallet upstairs ri

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

ght away to call the owner. The taxi driver allowed me to copy down the necessary

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

Combination pro

information…but he wouldn’t let the wallet out of his sight.

He did not speak Eng

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

lish well, but he made his message very clear. ‘My duty,’ he gestured to explain.

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

‘She left wallet in my taxi. I must report to company right away. Then I must retu

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

rn the wallet!’

This culture of honesty and personal responsibility deserves an h

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

onorable mention. Every year Singapore taxi drivers return hundreds of books, wall

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

ets and packages accidentally left behind by passengers.

The drivers consider it

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

Following aspects would a

a matter of honor to return the items in person. Taxi companies consider it a comm

dd to the challenges in developing combination products:

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

endable action and duly note the deed in a driver’s permanent record.

Bravo for t

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

he culture surrounding, and supporting, the taxi drivers of Singapore.

Key Learni

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

ng Point
-------------------------------------------------------------------

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

-------------
When a culture is strong and supported, individual behavior nat

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

Professional from academic institutions, pharmaceutical industries, health care indust

urally aligns with the intention and commitment of the group.

Action Steps

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

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

.

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

r> What can you do to promote a strong culture? What actions should you take, and

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

Companies that provide selfless information through particip

what traditions should you reinforce, to strengthen your culture and your values?

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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