Answers - Legal

The government is saying re-invest in America. Pour capital into th

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

e free markets, but why? If they do who will work in the new factor

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

Examples of combination products may in

ies and plants? Who will work in the new outlets? Who will man the

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

achinery? Unemployment is at a very low number.

Additionally why i

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

nvest when all you do is add potential lawsuits and liability to yo

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

Combination pro

r company? Indeed, why bother, it is a safer bet for corporations t

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

o hoard cash, enjoy the interest rates or if they decide to expand

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

hen do it away from the over regulation, extortion government lawsu

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

its.

Invest in other lands and outside the country. But if the oth

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

r nations like China, Mexico, India are risky, then sit on the cash

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

and do nothing that might jeopardize shareholders equity or quarte

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

Following aspects would a

rly profits. Makes sense right?

Under their breath and at parties

dd to the challenges in developing combination products:

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

hear whispers; Corporate Investment with All these Attacking Regul

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

atory Agencies; Bite Me. Wow, those are some harsh words, yet this

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

s how they feel and it is hurting America and our economic future.

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

It is time the G-darn government wake up and stop harassing busines

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

Professional from academic institutions, pharmaceutical industries, health care indust

people and making false claim and clean up its own act.

Otherwise

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

the indebted government, which has failed to protect the American

.

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

eople will have major turnover by The People who own it and the Cor

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

Companies that provide selfless information through particip

porations who control it. Consider all this in 2006. Vote for Lance

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 - Corporate Investment with All these Attacking Regulatory Agencies; Why Bother?

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