Answers - Insurance

The 2007 Atlantic Tropical Hurricane Season is rapidly approaching and folks a

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

re hoping that this season will be mild like the 2006 Tropical Hurricane Seaso

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

Examples of combination products may in

, which meteorologists said was about an average season. We all hope so, as th

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

memory of Katrina, Rita and Wilma, the three sisters from hell still lingers

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

n our minds. That insane 2005 Atlantic Tropical Season will take a great numbe

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

Combination pro

of years to forget. The folks in New Orleans and along the Gulf Coast may nev

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

er forget it.

This brings me to another topic that folks often do not discuss

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

Flood insurance. You see it is usually not the winds that do the most damage

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

rom a Hurricane it is the flooding that just ruins everything. Worse off nearl

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

all home owners policies do not cover such things? That's right, so it makes

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

ense to talk with an expert about this prior to the Hurricane Season and make

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

Following aspects would a

sure you are covered if you live in a Hurricane Zone.

Recently, there was a S

dd to the challenges in developing combination products:

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

preme Court ruling after one insurance company did not pay for flood insurance

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

due to a "fine print" mention which excluded wind driven rain. The Insurance C

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

mpany won the case and did not pay for the damages. Thus, in my opinion it mig

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

t be wise to talk with a certified expert insurance person and make sure you k

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

Professional from academic institutions, pharmaceutical industries, health care indust

now if you are covered yet.

When did Noah build the ark; before the rain, rem

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

mber? I certainly hope this article is of interest and that is has propelled t

.

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

ought. The goal is simple, to help you in your quest to be the best in 2007. I

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

Companies that provide selfless information through particip

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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You will find a brief introduction to the idea of Lean Healthcare. You can also find some excellent resources for further exploration.

Writing reports is one of the most powerful and cost effective marketing tools you have at your disposal. By offering free reports you not only promote your business and give propects valuabel information, you also gain valuable insight into your own customers and what they value about you and your business.

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Answers - Flood Insurance - Are You Positive You Are Covered?

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