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Does your medical insurance cover you completely? Most people are unaware of

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

exactly how much their medical insurance covers and are often shocked to find

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

Examples of combination products may in

that certain things are not covered after it is too late. One recommendation

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

that is often given in medical insurance articles is to ask your insurance ag

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

ent about Medi-Gap insurance or supplemental insurance.

If you have insuranc

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

Combination pro

from your employer and it all seems too complicated to you, then you need to

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

consult an expert on this. And this is something you might do every so often

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

as sometimes large companies will modify their medical coverage insurance for

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

their employees. Of course they will notify you, as required hopefully, but

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 you do not understand it all you need to ask someone who knows.

Only about

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

58% of the businesses in the United States offer health insurance to their e

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

Following aspects would a

mployees and the trend seems to be that this percentage is going down not up.

dd to the challenges in developing combination products:

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

Meanwhile the premiums keep going up, which are over taxing businesses and re

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

sulting in the cutting of types of coverages says the GAO.

Most medical insu

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

ance just does not provide for every illness or injury and this is why it is

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

often wise to have supplemental insurance, but you need to shop around and ta

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

Professional from academic institutions, pharmaceutical industries, health care indust

k to an expert in these things.

That is what I did, like you I was concerned

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

. I certainly hope this article is of interest and that is has propelled thou

.

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

ht. The goal is simple; to help you in your quest to be the best in 2007. I t

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

Companies that provide selfless information through particip

hank 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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