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In Oklahoma, identity theft is the most common complaint by consumers. This has b

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

een the case for the last seven years. However, the cases of identity theft have

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

Examples of combination products may in

ropped despite this statistic. And Oklahoma is now the 23rd most popular state fo

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

r identity theft compared to its previous position of 18th.

Something is going ri

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

ht and the increase in identity theft is being matched - albeit slowly - with our

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

Combination pro

ncreased awareness of the crime. Much is being learned and more importantly, disse

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

minated throughout the world on the origins and methods of identity thefy. Ordinar

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

people are becoming increasingly aware of the threats upon them. I believe people

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

are also beginning to realise the difficulties that they will suffer if they, too

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

are identity theft victims.

However, identity theft is still a major crime throu

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

hout the nation. More than 8 million dollars were lost in 2005. Increase in surv

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

Following aspects would a

eillance and vigilance led to 185 arrests during 2005 with a recovery of $1.5 mill

dd to the challenges in developing combination products:

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

on. This trend is hoped to continue but the increase in theft needs to be matched

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

by the increases in technology and in manpower.

Oklahoma now has a task force of

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

state, local and federal agents who’s targeting the crime of identity theft and ot

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

er related crimes. This task force includes people from the postal inspection tea

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

Professional from academic institutions, pharmaceutical industries, health care indust

m, the IRS, the secret service, the FBI, the U. S. Attorney, and Oklahoma County D

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

strict Attorney. Also included are the Oklahoma City Police and Mid-west City Pol

.

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

ice and the highway patrol.

As with everything, the criminals will always be one

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

Companies that provide selfless information through particip

tep ahead. But their empire will be short lived with increasing vigilance and care

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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