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It seems a day doesn’t go by without a company announcing it has lost or had customer data s

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

tolen. TransUnion Credit Agency has now joined the parade of identity theft.

TransUnion Cre

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

Examples of combination products may in

it Agency

In late summer, TransUnion discovered that over 3,600 consumer records had been s

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

tolen from a regional sales office in California. The company indicated the data was stored

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 an independent desktop computer. The company believes the computer was stolen as part of a

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

Combination pro

burglary, not an intentional intent to steal consumer data.

There are more than a few seri

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

us issues with TransUnion’s position and action. First, consumer data shouldn’t be stored on

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

a desktop computer sitting on a desk. More importantly, what is the data doing on a compute

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

in a regional SALES office? TransUnion is supposedly looking into these issues.

Insultingl

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

y, TransUnion has suggested the stolen data is not a big deal since the computer is password

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

protected. If TransUnion really thinks a password protected desktop computer is going to kee

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

Following aspects would a

p someone from seeing the data, it should lose its right to do business. A hacker would smir

dd to the challenges in developing combination products:

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

at that.

Bigger Issues

3,600 consumer records is really a small issue when considering th

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

e big picture of consumer privacy issues. It does, however, portend to a bigger problem.

T

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

ansUnion is one of the big three credit reporting agencies with Experian and Equifax being t

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

he other two. It strikes me that the databases of these three companies must be the Holy Gra

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

Professional from academic institutions, pharmaceutical industries, health care indust

l of Identity Theft. What happens if someone gets into one of these systems?

What happens

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

if an employee with access to the data gets tempted? Keep AOL in mind. An AOL employee was r

.

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

cently sentenced for selling the AOL member list to spammers. How much do you think a crimin

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

Companies that provide selfless information through particip

al organization would pay for a copy of consumer records in a credit agency database?

A lot

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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