Answers - Legal

Sales of Sports Utility Vehicles (SUVs) have sky-rocketed in the United States, accounting for over 25 perc

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

ent of all new-vehicle sales in 2004 and representing almost 14 percent of all registered vehicles in the n

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

Examples of combination products may in

tion, with more than 22 million on the road. Many buyers ironically cite safety issues for their decision,

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

claiming that they feel more protected because they are larger, heavier and higher than cars. Unfortunately

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

when it comes to rollover accidents - the leading cause of death on America's highways - SUVs are among th

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

Combination pro

e riskiest vehicles driven today. New fatality statistics show that over 12,000 people died last year in ro

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

lovers, with SUVs averaging the highest rate at nearly 62 percent.

Americans penchant for large SUVs make

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

the roads even more dangerous than they should be. These large vehicles with a narrow and unstable wheel b

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

se combined with a high center of gravity and poor safety design kill thousands of people each year because

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

few understand how dangerous they are. Automakers do not go out of their way to improve their products or

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

alert consumers to their dangers, and this combined with a false sense of security that larger vehicles are

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

Following aspects would a

safer make them deadly killing machines.

Pedestrians share the roadways with motorists and have the right

dd to the challenges in developing combination products:

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

of way, but no person can stand up to a car that is barreling down on them. Physics will prevail, and pede

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

trian knockdowns are becoming more and more common now that the roads are more and more clogged. Many pede

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

strians knocked down by cars suffer extensive injuries such to their head, spine, bones, internal organs, a

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

d general health.

Being paralyzed is one of the worst possible outcomes that can come out of a car acciden

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

Professional from academic institutions, pharmaceutical industries, health care indust

t. Paralysis occurs when the vital nerves that control various body parts are damaged or severed. This us

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

ally happens when there is a traumatic impact to the neck or spinal cord. As a result, parts of a victim’s

.

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

body will no longer retain the same mobility or sensation as they once had. Many times hands won’t be abl

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

Companies that provide selfless information through particip

to clinch; legs won’t be able to work and in severe cases entire portions of the body are left immobilized

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 - SUV Rollovers, Car Accidents & Vehicle Crash Injuries

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