Main Subject - Business

In short, my bank made bit of a mess of opening a new business account for me. An

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

d I waited for about 6 weeks before I eventually received a paying in book and che

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

Examples of combination products may in

ue book.

They also told me that I wouldn't be able to see this account along with

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

my other accounts when I used their internet banking facility. This would have be

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

n very inconvenient when trying to see my balances or transferring funds between a

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

Combination pro

counts.

My bank manager was clearly very embarrassed by these problems. He sent

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 several letters of apology and also a present of a very nice Cross roller-ball p

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

n.

At one point, I was getting so frustrated with what was happening that I actua

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

ly thought about changing banks. But on second thoughts decided that I ought to 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

least telephone him and explain my frustrations. By letting him know how I felt,

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

he at least had a chance to put things right.

Finally, he did manage to solve all

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

Following aspects would a

the problems. My cheque books did arrive. And he managed to get all my accounts

dd to the challenges in developing combination products:

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

set up on one internet account.

I was a happy customer once more. And I will be

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

taying with this bank.

But what was it that saved the day. Was it the letters of

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

apology? Was it the Cross pen?

No. What convinced me to stay with this bank was

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 my manager had some temporary cheques made up for me and then drove 10 miles

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

Professional from academic institutions, pharmaceutical industries, health care indust

o hand deliver them to me.

I actually only needed to use one of those temporary c

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

eques. But it was the manager's commitment to me as a customer that made the day.

.

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

Interestingly, the pen didn't save the day. But it is a lovely reminder of my ma

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

Companies that provide selfless information through particip

ager's commitment and care.

How would you and your team demonstrate that you care

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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