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First, let us acquaint ourselves with some alarming statistics: 250,000 people have died in al

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

cohol-related accidents in the past 10 years; 25,000 people die each year in alcohol related a

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

Examples of combination products may in

cidents; 500 people are killed weekly and 71 people daily in alcohol-related accidents; one Am

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

rican life is lost every 20 minutes in an alcohol-related car crash; and one out of every two

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

Americans is likely to be involved in an alcohol-related accident in his lifetime. Every year,

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

Combination pro

708,000 persons are injured, 74,000 of them seriously, in alcohol-related crashes. About 2,000

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

people receive injuries each day in alcohol-related accidents.

A recent study reveals that al

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

cohol-impaired drivers cost American taxpayers $21 - $24 billion dollars per year. According t

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

a recent National Geographic report, alcohol abuse costs American society $136 billion and 65

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

000 lives annually.

The rise in the number of accidents often goes hand-in-hand with binge dr

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

nking, meaning having at least five drinks at a time. Binge drinkers were 13 times more likely

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

Following aspects would a

to report driving while they were alcohol-impaired, and most of them admitted they often had

dd to the challenges in developing combination products:

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

ar more than five drinks per binge.

If you receive injuries in a drunk-driving accident, you

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

ay be entitled to compensation from the drunk driver or his insurer. Under certain circumstanc

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

es, even injured pedestrians and their close family members are entitled to receive compensati

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

n. Such compensation usually includes payment for medical treatment, past and future lost inco

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

Professional from academic institutions, pharmaceutical industries, health care indust

e, and emotional distress damages.

In some limited instances, the injured person is entitled

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

to get recovery from the provider of alcohol to the driver, usually a bar or restaurant. Such

.

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

ases against third parties are, however, more complicated and difficult to prove. Punitive dam

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

Companies that provide selfless information through particip

ges are meant to punish malicious or reckless drivers, and to deter such conduct in the future

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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