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"Your own ways have brought this down upon you; it is a bitter dose of your own medicine, stri

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

king deep within your hearts" (Jeremiah 4:18 TLB).

We seem to have abdicated accountability.

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

Examples of combination products may in

hat an onerous word, accountability, in today's free-wheeling lexicon of rights and nuances. A

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

d yet our righteous God demands an accounting of our thoughts and actions. We might do well to

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

remember that the one does follow the other, too. Otherwise, advertising would be for naught.

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

Combination pro

t is silly to say that what we see and hear day in and day out has no effect on us.

Chuck Swi

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

doll gives us four qualities of accountability in his book, Living Above the Level of Mediocri

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

ty:

Vulnerability – capable of being wounded, shown to be wrong, even admitting it before bei

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

g confronted.

Teachability – a willingness to learn, being quick to hear and respond to repro

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

f, being open to counsel.

Availability – accessible, touchable, able to be interrupted.

Hone

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

ty – committed to the truth regardless of how much it hurts, a willingness to admit the truth

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

Following aspects would a

o matter how difficult or humiliating the admission may be. Hating all that is phony or false.

dd to the challenges in developing combination products:

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

We had five sons and I recall buying a shirt for one of the younger boys that said, "The devi

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

made me do it." He was a mischievous little guy and I thought the shirt was hilarious. Of cou

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

rse I never took it seriously and I'm sure he didn't when he was punished for some of his shen

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

nigans. But as the decades have gone by and I've witnessed all the lawsuits flooding the land

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd everyone blaming everyone else, I wonder if the devil is laughing at us all.

The first it'

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

-your-faulters were Adam and Eve, and we've been playing the blame game ever since. Amazing! B

.

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

t somewhere along the continuum of growth we learn to say, "OK, I did it, I take full responsi

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

Companies that provide selfless information through particip

ility, and I'm sorry for whatever grief and inconvenience I've caused."

Who wants to go first

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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