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Workplace deaths and injuries may be decreasing according to recent statistics publ

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

ished by the United States Department of Labor and Industries; however, when workpl

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

Examples of combination products may in

ce accidents do occur, the injuries are usually serious and sometimes fatal. Constr

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

ction workers, especially, are in a high-risk industry, and more work for construct

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

ion companies means more pressure on construction workers to produce.

Injury rates

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

Combination pro

are high in the building trades, in natural resource extraction and in some manufac

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

uring industries. According to Leonard Smith, a spokesman for the Teamsters union l

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

ocal headquartered in Seattle, Washington, some employers are just not making safet

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

a priority. According to the U.S. Bureau of Labor Statistics, it is estimated that

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

1,200 American construction workers die in falls on the job each year. While the co

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

struction industry only employs about 7 percent of the nation's workforce, construc

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

Following aspects would a

tion sites accounted for 21 percent of workplace deaths.

One of the possible solut

dd to the challenges in developing combination products:

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

ons offered to help decrease the number of construction work site injuries is to in

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

rease the inspectors-per-worker ratio in the states that do not have enough inspect

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

ors for the size of the state. For example, Idaho has just nine accident investigat

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

rs covering the entire state whereas Washington just hired 11 additional inspectors

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

Professional from academic institutions, pharmaceutical industries, health care indust

for the state assigned solely to examine and certify cranes.

If other states would

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

follow Washington's lead and hire more inspectors, the number of work site injurie

.

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

and deaths may decrease in time. In the meantime, industry workers must continue t

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

Companies that provide selfless information through particip

be very careful at their work sites and be aware of the hazards that surround them

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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The dreadful events like Hurricane Katrina, Hurricane Rita and Tsunami have eaten a large number of buildings and dwellings. Due to this, there are chances of gigantic growth in the construction industry. It is expected that the industry will grow to $1.1 trillion in 2006 and $1.2 trillion in 2007.

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