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Quite a few years ago I read a small ad in the Sunday morning Times Picayune News Paper. The ad said that Frank Sinatra wou

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

ld be appearing at the University of New Orleans Arena for one performance only on a certain date about a month away.

I tho

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

Examples of combination products may in

ught to myself, I am going to go to the D. H. Holmes Department Store first thing Monday morning where Ticket Masters was lo

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

cated and purchase two tickets. I am going to be the first one there and buy two front row seats. I will surprise my wife M

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

rie and she would love this.

The next morning I arrived at the shopping mall early. The outside door to the Department stor

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

Combination pro

e was locked. The store opened at 10:00 am. I decided to go into the mall with many stores and go over to the doors that l

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

ed into the Department store. I did not know what was happening, however hundred and hundreds of women were gathering by t

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

he large cage like gate to also get into the store.

I said to myself, there must be a sale going on today. You could see t

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

rough the large cage like gate to the other side of the store where the outside door was located. A crowd was gathering the

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

re also.

The manager went to open the doors that led to the outside of the store first. All the women started yelling at h

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

im to open the mall gate first. The women on the at the outside door rushed into the store and ran through the isle like th

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

Following aspects would a

ey were giving away something. When the manager came over and started the large cage like gate to rise slowly, women were l

dd to the challenges in developing combination products:

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

ying down on their stomachs to crawl under the gate. They begin running through the store to the escalators.

I walked ver

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

y calmly through the store thinking to myself; it must be a big sale. When I reached the top of the escalator I was shocked

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

to see the line to Ticket Masters was doubled wrapped around the second floor of the department store. All these people we

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

re here for the same reason I was. They wanted tickets to see Frank Sinatra in person.

Of course all the tickets were sold

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

Professional from academic institutions, pharmaceutical industries, health care indust

out in no time. I never had a chance to get two tickets, must less front row seats. I had a good laugh at myself.

I thoug

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

ht to myself, how can a man over 65 years of age get this much attention from all of these women. Then I remembered, he can

.

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

not only sing, he could deliver a message in his songs like no one else. The thought is always more precious than the gift.

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

Companies that provide selfless information through particip

However how you deliver the thought is of the most importance. How may I serve humanity with humility? What can I 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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