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Type 2 Diabetes is one of the leading causes of blindness, limb amputation, kidney proble

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

ms and male impotence in the United States and growing throughout the world. Other seriou

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

Examples of combination products may in

complications include heart disease, stroke, and nerve damage.

It is a nasty disease th

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

t can just literally sneak up on you. It has been called a silent killer. The symptoms ca

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

take months if not years to manifest themselves. In that time enormous damage is done to

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

Combination pro

the body and time wasted on fighting the disease.

My problem was, way back when, I didn'

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

take it seriously for two reasons. First I was partially in denial. Secondly I didn't se

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

e the end result. In other words, it didn't seem serious to me and no one helped drive th

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

seriousness home.

Can I be the only person in the world who has ignored diabetes or has

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

not been diagnosed for the disease? I don't think so!

It really helps if someone literal

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

y scares the s..t out of you by showing you a dialysis chair, a blind person, or an amput

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

Following aspects would a

e just to get your attention. Or a doctor, nurse or medical professional who might take t

dd to the challenges in developing combination products:

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

e time to explain the short and long term consequences and complications you will run int

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

by ignoring the disease.

In my personal experience, when I found out, the doctor told m

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

e in such a matter of fact way as to not create any sense of urgency. It was like "oh you

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

have a cold-here are some pills." He didn't last as my doc.

Once you have been diagnosed

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

Professional from academic institutions, pharmaceutical industries, health care indust

it is incumbent upon you to take an aggressive course of action to get the disease under

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

ontrol and keep it under control. The end result of a fuller, longer life is worth the ef

.

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

ort.

Not taking any action and ignoring the disease even for a year can shorten your lif

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

Companies that provide selfless information through particip

and quite possibly lead to very serious complications that can kill you. It is up to you

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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A new critical illness policy from the Prudential covers illnesses that others don't even consider. In theory it sounds good, but check the extent of the cover and ask yourself if it's right for you.

Politics may make strange bedfellows in the estimation of those who do not look to see the families who play both ends against the middle.

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