Actual - Legal

Many folks believe we should shame scam artists as a punishment. In theory this works great,

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

but in practice it does not work at all. In fact, it leads to horrible consequences. One so

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

Examples of combination products may in

cialist regulator gave a speech that this might be the best way to treat business scam artis

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

t offenders. But a real scam artist would not care and a real decent person miss labeled wil

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

have been slandered and libeled.

It doesn't work, indeed, I have been shamed by a competit

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

Combination pro

or all over the Internet and at the sale of my company I think it probably cost me six milli

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

on dollars in the sale price. Worst off the competitor who did it is a scam artist, not even

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

a real competitor. People are harmed and damaged all the time from this.

Worse off the law

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

are misused by the governments and lawyers make up stuff in lawsuits. It amounts to a witch

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

-hunt and extortion as the government regulatory bodies, which every year grow in bureaucrac

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

y. The number of Press Releases they send out when they THINK they have located a scam arti

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

Following aspects would a

st based on complaints from competitors has gotten to the point of 8,000 or more. Thus they

dd to the challenges in developing combination products:

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

re scamming the public into believing they are actually protecting them. When their chief co

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

ncern is to con the public into believing they are doing due justice.

Lawyers are always tr

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

ying to make a buck, by getting the government to render decision on a company so they can p

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

ounce on them. Yet the lawyers are the ones who have hijacked the law in this case. Our regu

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

Professional from academic institutions, pharmaceutical industries, health care indust

atory bodies thus using this “shame methodology” are shaming themselves as they

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

purport Truth, Justice and the American way.

I certainly hope this article is of interest a

.

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

nd that is has propelled thought. The goal is simple, to help you in your quest to be the be

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

Companies that provide selfless information through particip

st in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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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