Answers - Legal

There are many people who believe that the food and drug industry are

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

evil and that the substances that are in these products are killing

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

Examples of combination products may in

people. It is true that we do not know yet the long-term effects of m

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

any of the changes we are making to our food processing methods or th

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

long-term effects of many of the drugs that we prescribe to prevent

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

Combination pro

disease.

We do know that many of these drugs work quite well and tha

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

t people are living longer and happier lives, as well as being health

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

well into their 80s. These are all great things and yet the purists

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

and organic progressives are warning people that they are dying becau

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

se they are eating and ingesting these things.

The more that these p

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

ople make a nuisance the more regulations that will be placed on the

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

Following aspects would a

food and drug industry, this will raise the costs and prevent researc

dd to the challenges in developing combination products:

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

h. We need more research and we must press on to discover how it all

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

works and use the best methods to help humans live longer and health

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

er lives.

Before you listen to the rabble rousers, perhaps you might

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

consider these thoughts and realize that there is a lot more to this

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

Professional from academic institutions, pharmaceutical industries, health care indust

issue then is offered by those that complain. I certainly hope this

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

rticle is of interest and that is has propelled thought. The goal is

.

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

simple; to help you in your quest to be the best in 2007. I thank you

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

Companies that provide selfless information through particip

for reading my many articles on diverse subjects, which interest 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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Answers - The Coming Food Shortages Thru Over Regulation Caused by the Masses

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