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I came across this gem some years back. If we apply this to

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

our family and friends and our not-so-friendlies, how many m

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

Examples of combination products may in

inutes do WE have? Truly something to think about!

At the b

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

ginning of the war it is said that a clergyman appeared befo

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

re Bishop William Taylor Smith, chaplain general of the Brit

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

Combination pro

sh Army, and applied for chaplaincy. Because he was a part o

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

f the great church of which the bishop was a leader, he felt

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

reasonably sure of the appointment. It is said that Bishop T

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

aylor Smith looked intently at him for a moment, then taking

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

his watch from his pocket said,

“I am a dying soldier on th

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

e battlefield. I have three minutes to live. What have you

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

Following aspects would a

to say to me?”

The clergyman was confused and said nothing

dd to the challenges in developing combination products:

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

Then the bishop said, “I have two minutes to live. What ca

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

n you tell me to help my soul?” and still no response.

Then

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

said the bishop solemnly, “I have only one minute to live!”

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

With that the clergyman reached for his prayer book, but th

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

Professional from academic institutions, pharmaceutical industries, health care indust

bishop is reported to have said, “No, not that at such a ti

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

me as this,” and because the clergyman had nothing to say to

.

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

the dying soldier upon the battlefield, he did not receive a

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

Companies that provide selfless information through particip

ppointment.

"The Minister's Handicap," by J. Wilbur Chapman

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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