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This is a question about architecture? It is about whether the role of your government fits the society it i

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

s managing. And a specific example is what limitations a government has to face in solving healthcare proble

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

Examples of combination products may in

ms.

Heroic governments are those that summons a primary role in society on certain topics. This could eithe

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

r be related to an internal issue or to an external problem. The last one often demands a heroic action from

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

a government although we have seen that these heroic actions are often not effective. The problems in the w

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

Combination pro

orld are becoming too complex to be solved by a single hero. Think for yourself about the specific examples.

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

“Internal-wise” and in current (western) societies a government is best managed by a non-heroic organizati

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

on. The role of the government is like the one of the administration of a large corporation. It is placed in

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

the center of the organizational structure so that it is able to offer support for any remote business unit

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

or division. In difference with the corporation, the government is not managing society like an corporation

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

does manage an organization of people. A company is managing an organization which legitimates some heroic g

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

Following aspects would a

overnment structure.

If you agree with this than how would you respond on the following question. Should a

dd to the challenges in developing combination products:

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

government ban all smoking in order “to solve” a healthcare problem? The one of long cancer.

I think it sho

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

uld not. A government is restricted to a central policy by issues laws which in most cases involve taxes. Ci

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

garettes have already a tax burden un-favoring its use. That there are additional laws that ban smoking from

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

public areas (public institutions, companies, etc) is alright, because the passive smoker problem can’t oth

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

Professional from academic institutions, pharmaceutical industries, health care indust

erwise be tackled (by issuing a tax). In this way a government rescues the passive non-smoker. This is a pe

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

rfect role for a government; supportive but not interfering more than necessary. The purpose of a total ban

.

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

on smoking would go too far. The purpose would then be to solve the health care problem of lung cancer in g

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

Companies that provide selfless information through particip

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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