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Although 2006 was a relatively calm year with only 2 named storms hitting the U.S., the Nat

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

ional Oceanic and Atmospheric Administration (NOAA) Climate Prediction Center is projecting

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

Examples of combination products may in

a much more active Atlantic Hurricane Season for 2007. Based on the current oceanic surfa

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

e temperatures, the scientists are predicting between 13 and 17 named storms, 7 to 10 of wh

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

ich will become hurricanes, and of those 7 to 10, 3 to 5 could be major hurricanes, a Categ

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

Combination pro

ry 3 or higher.

If the predictions are true, we only have to look back to 2005 to realize

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

what we may have to look forward to here in Florida. We had widespread evacuations. Many

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

f us experienced days, even weeks without electricity. There was property damage and destr

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

uction everywhere. If it happens again, are you prepared?

If you haven’t done so already,

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

now is the time to get your family ready in case a disaster strikes. Waiting for the first

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

hurricane watch is too late.

You can create a personalized Family Plan, which will includ

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

Following aspects would a

e:

· Amount of food and water needed for your family and pets
· Evacuation maps

dd to the challenges in developing combination products:

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

Local emergency contact information

The system creates checklists of recommended items an

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

d specific quantities of water based on your size family. It also emphasizes the importanc

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

of keeping copies of important documents such as insurance papers, birth certificates, and

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

bank account numbers in a dry, plastic container for easy retrieval.

But what if disaster

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

Professional from academic institutions, pharmaceutical industries, health care indust

does strike your family home; will your insurance company respond appropriately, timely and

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

treat you fairly? The 2005 hurricane season found many homeowners fighting with their adj

.

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

ster to replace roofs, repair water damage and settle claims. Some homeowners are still fi

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

Companies that provide selfless information through particip

ghting their insurance company and for some it has been two years since the damage occurred

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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