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We may see some interesting type lawsuits and new case law develop in t

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

he very near future as Ford Motor Company’s stock drops. Why you ask? W

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

Examples of combination products may in

ll it appears Ford Motor Company is going to go private, but in doing s

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

some might say that it is purposefully finding things to do in order t

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

lower its stock price prior to going private. Will those shareholders

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

Combination pro

who have lost money due to the fast stock price drop sue? Will some law

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

er try to file that class-action case against Ford Motor Company?

This

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

will be an interesting class-action lawsuit in that they are damned if

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

hey do and damned if they don’t and this could prevent future companies

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

from attempting to go private. More and more companies are considering

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

this due to the massive over regulation of the SEC Securities Exchange

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

Following aspects would a

ommission and the incredible class-action lawsuits from groups of minor

dd to the challenges in developing combination products:

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

ty investors.

Would such a suit hold water? No, probably not really be

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

cause all the US Automakers are having troubles. Even DaimlerChrysler i

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

attempting to hold their head up high as they manuerver thru though ti

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

es and turbulent waters. General Motors, DaimlerChrysler and Ford Motor

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

Professional from academic institutions, pharmaceutical industries, health care indust

Company have all announced lay-offs. Ford Motor Company announced 300,0

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

00 lay offs to occur over the next few years and 14,000 will be leaving

.

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

immediately whether they take the buy-put severance pay package or not.

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

Companies that provide selfless information through particip

So, there are certainly some issues here as this game strategy un-folds

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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