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The unfortunate grass fires in Central Florida are setting the State

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

of Florida up for some pretty rough times in the future as the 2006

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

Examples of combination products may in

Atlantic Tropical Hurricane Season. As the fires burn through the wa

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

er sheds that would normally soak up the torrential rains that Large

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

Size Hurricanes often bring as they drop up to 15 inches of rain in

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

Combination pro

10-18 hours or less.

Often the Category or strength of the Hurrican

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

are not as damaging to the torrential flooding as the absolute size

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

of the storm. In fact a very slow moving Category One can cause muc

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

more damage thru flooding than a faster moving Category III which b

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

eaks apart as it hits land only to reform once it crosses the state

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

nd ends up either in the Gulf or the Atlantic Ocean for another go a

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

Following aspects would a

t human civilizations.

How bad are these fires? Well they have burn

dd to the challenges in developing combination products:

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

d thousands of acres and as Florida heats up things are pretty dry.

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

ithout that shrubbery the folks living on the giant sandbar are in s

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

evere risk from the flooding, which could cost Insurers, residents a

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

d the US Government Billions.

When does Hurricane Season start, wel

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

Professional from academic institutions, pharmaceutical industries, health care indust

some say within week, but officially the first named storm is not s

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

uppose to occur before June 1, yet the last two Hurricane Seasons st

.

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

rted early by at least one week and meteorologists are expecting the

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

Companies that provide selfless information through particip

same this year and FEMA is ready just in case. 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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