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Is your management team able to protect proprietary information?

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

You have to be in this day and age of Corporate Espionage. Not

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

Examples of combination products may in

to mention the laws on identity theft. If you lose valuable empl

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

oyee personal information you could be sued or worse yet be sued

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

by the government, as there are now rules and regulations that

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

Combination pro

you must protect your company’s employees information.

An

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

d failure to notify them even if it was a criminal act can get y

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

ou in serious hot water with stupid little Justice Department Ag

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

encies like the; FTC or Federal Trade Commission. You must there

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

fore protect your company’s data.

It is amazing of course

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

we have the government suing companies over this stuff because

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

Following aspects would a

the Federal Trade Commission themselves have lost personal data

dd to the challenges in developing combination products:

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

for their own employees and they are the agency entrusted to pro

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

tect the American People over identity theft.

Shear incompetenc

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

e, yes I know, but that is the double standard we have. The gove

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

rnment each year gives away or has stolen more information than

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

Professional from academic institutions, pharmaceutical industries, health care indust

any other entity on the planet. The Federal Trade Commission of

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

course ought to know better, but they don’t in fact I beli

.

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

eve them to be the most inefficient agency on the Planet in fact

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

Companies that provide selfless information through particip

in my personal and professional opinion. 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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