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Most professions now have; Know your customer laws, but are these laws adversely a

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

ffecting customer service? Are your customer laws causing professionals to ask too

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

Examples of combination products may in

many questions of the customer that the customer wishes to keep private? You see,

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

due to all the spyware, identity theft and privacy issues in the news, we see so

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

any people afraid of strangers and such. This means that they are scared to give a

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

Combination pro

way personal information to anyone, even the professionals such as doctors, lawyer

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

s, accountants, bankers, stock brokers, etc.

But why are they afraid in the first

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

place? Well, because the government agencies have scared the American People abou

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

identity theft. What is very ironic is that indeed, the government gives away the

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

most information of any organization or corporation due to all the forms you have

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

to fill out, becoming public record. Corporations and professionals have a vested

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

Following aspects would a

interest in keeping your data safe, because they do not wish their competitors to

dd to the challenges in developing combination products:

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

have it.

Why do so many professionals ask for the information, which seems irrele

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

vant and too personal to give them? Well, because of government sanctioned; Know y

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

our customer laws. And I am here to tell you it is causing problems in the market

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

place and hurting the very professionals who are there to help. Help with what?

W

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

Professional from academic institutions, pharmaceutical industries, health care indust

ll many times they are there to help people work thru the maze of regulations and

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

bureaucracy created by the government, who also has scared people into fearing ide

.

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

ntity theft, of which government is the biggest purveyors of your personal informa

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

Companies that provide selfless information through particip

tion. See the problem yet? I bring this up because something must be done about it

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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The competitiveness of the job market makes it imperative that employees keep others informed of their successes and victories. While this practice is not recommended for social settings and may even be counterindicated among certain cultures, it is rapidly becoming the preferred practice in the workplace.

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