E-Articles - Reference and Education

We need to change our Educational System, it is not good enough and just like other major pro

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

blems like our political system and health care system, it's broken. We all know the educatio

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

Examples of combination products may in

nal system is not working and most public schools are nothing more than glorified baby-sittin

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

, rote memorization centers of indoctrination. What value is this to our society or civilizat

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

ion really?

Interestingly enough everyone freely admits the educational system is broken and

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

Combination pro

that it needs to be fixed and yet trying to get anything done with the current barriers of th

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

e status quo is a little unnerving and who has the time to deal with it all?

Indeed, this is

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

to be expected, you know the Status Quo, it's everywhere. Let me tell you a little story. I

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

ad brought forth a "Neighborhood Watch Patrol Plan" which has been successful, everywhere we

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

have instituted it. Yet, every time it is suggested we hit a literal brick wall due to the st

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

tus quo (local law enforcement agencies). Amazing, that they are not interested in solving th

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

Following aspects would a

e problems, making it better or winning, only in their fiefdoms.

This is human nature of cou

dd to the challenges in developing combination products:

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

rse, still it is unacceptable, surely mankind is better than this? It takes a lot to be a cha

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

ge maker, and it is worthy, but you have to be willing to go the distance, few are. But they

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

finally did instituted my Neighborhood Mobile Watch Program in NYC with the Taxi Cabs, so eve

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

tually if you press on, you can get it done.

So, it is possible to change things that are br

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

Professional from academic institutions, pharmaceutical industries, health care indust

oken and solve the challenges and problems of our day, but it takes time and there are emotio

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

nal costs and some hard headed people in the way. Many people have just given up on their loc

.

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

l school systems and turned to Home Schooling and the Status Quo is worried about the rapid g

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

Companies that provide selfless information through particip

rowth in home schooled families as well they should be. A little competition is good for them

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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