Answers - Legal

In the United States we have a severe problem in our healt

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

h care system and the cost over runs are ruining retiremen

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

Examples of combination products may in

s, those on a fixed income and increasing health care insu

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

rance premiums to an alarming rate. So much so that many c

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

rporations are telling worker unions that they cannot affo

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

Combination pro

rd the current benefits. But it gets worse with shortages

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 nurses at hospitals and for in-home care.

Why is all th

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

is happening? Well many including myself believe that the

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

llegal aliens and the legal lawyers are causing it. The il

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

legal aliens come in and get free medical attention, but n

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

ver pay the bill and the legal profession, which could not

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

Following aspects would a

exist without the medical profession steals the rest. How

dd to the challenges in developing combination products:

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

you ask well thru medical mal-practice insurance.

If some

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

hing is not done to stop these abuses then many believe th

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

at we are in dire straights and that Medical Mal-Practice

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

s it Bankrupting our Health Care System. If the United Sta

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

Professional from academic institutions, pharmaceutical industries, health care indust

tes of America does not start regulating lawyers and throw

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

ng them in jail for false claims and lying in courts of la

.

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

w and purposefully and willfully manipulating our health c

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

Companies that provide selfless information through particip

re system then all will be lost. So, consider this in 2006

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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Answers - Medical Malpractice: is it Bankrupting Our Health Care System?

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