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I applaud Monsanto for their R and D. I would like to meet the head R and D m

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

an there and shake his hand for his drive and stick-to-it-ness to find soluti

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

Examples of combination products may in

ns to feed the world. I have seen the animosity towards terminator and GM 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.

s, but I have also seen children dying of malnutrition and felt sick to my st

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

mach as I knew they would not last more than a year like that. Malaria, or so

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

Combination pro

ething would get them first. It was a sad day boarding that plane and thinkin

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

g in 12 hours I would be back in the states and they would be living there an

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

dying of some awful affliction. Not many opportunities there, not very fulfi

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

led human lives really.

Some environmentalists, rural farmers are up in arms

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

over the GM seeds and are using smear campaign tactics against Monsanto. Ther

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

are so many seed companies, which are poised to take the market if Monsanto

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

Following aspects would a

was to force this product onto a world market when in fact the world market d

dd to the challenges in developing combination products:

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

d not desire it. Cargill is no little company and the world is not with out c

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

mpetition for seeds.

For Monsanto, GM Terminator seeds are one of their line

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

of seeds, I see by these public relations attacks and articles out in the wo

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

ld press that Monsanto has a small PR issue ahead. Yet simultaneously from a

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

Professional from academic institutions, pharmaceutical industries, health care indust

logical perspective the GM Terminator seeds make so much sense as we need to

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

eed the world more efficiently. Please think on this, people are dying of mal

.

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

utrition and GM seeds maybe part of the answer, lets work together on this co

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

Companies that provide selfless information through particip

cept. Who knows what we can accomplish with the help of this ongoing research

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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