Actual - Legal

No human civilization runs perfectly, that is not to say one couldn’t, as it is possible. Sure

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

ly the United States runs better than most civilizations on the Planet in this present period,

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

Examples of combination products may in

but with its top heavy Government it is not the epitome of efficiency by any means. As a matt

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

er of fact almost every problem in our modern society can be traced back to the inefficiencies

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

of our humongous and ineffective bureaucracy.

Whether you are a lover of the mess of governme

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

Combination pro

nt bureaucracy or not, or even if you work in it, can you name any thing that government does

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

well? Well, don’t feel like you have failed to guess the answer to the question; it is a trick

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

question, because there is nothing that our government is exceptional at, besides wasting our

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

money. Does this mean we should shut our government down? Of course not it is a necessity of 3

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

00 million people living together in harmony.

Unfortunately government has only a few respons

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

ibilities, one of their most important responsibilities is to protect her people, well we know

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

Following aspects would a

they cannot do that. Look at our leaking borders, the 9-11 attack or even the response to maj

dd to the challenges in developing combination products:

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

r disasters. The fact is that the government is inefficient in every single thing they do, inc

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

luding those agencies, which monitor other agencies; they themselves are wasting money.

Since

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

the government is so inept and the corporations make them look so bad, they keep increasing r

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

egulation, yet conveniently forget that they are inherently corrupt and wasteful with the most

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

Professional from academic institutions, pharmaceutical industries, health care indust

important job of all, working for us. It is our government and therefore the inefficiencies ar

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

e our fault. Yet when was the last time you stood up and said anything about it? You see it is

.

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

You that is causing all this, because you are not facing the reality of the blob of bureaucra

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

Companies that provide selfless information through particip

cy and you have accepted it as business as usual. You know what? It is not okay. Think on that

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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