Actual - Insurance

If you are a small business employer and even have only one employee then you

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

better have workmen's compensation insurance, if you don’t in some places yo

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

Examples of combination products may in

u can be thrown in jail. Employees can get hurt anytime and you just never kn

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

ow what can happen. If they are on their way to work or on there way home you

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

small business might be liable for some or all of their lost wages if they a

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

Combination pro

re injured. This is my view of the situation.

Even with all the CYA's in the

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

world and manuals on ergonomics and special procedures this does not allevia

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

e your responsibility. You might have a very safe work space, but as they say

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

; things happen. Unfortunately, we found in our company that the Workmen's Co

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

mpensation Insurances rates have increased dramatically. We believe this is f

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

om all the lawsuits and over regulation of the insurance industry. Now there

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

Following aspects would a

are fewer companies that provide this insurance. This appears to have driven

dd to the challenges in developing combination products:

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

the cost up substantially.

Nevertheless, not having Workmen's Compensation I

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

nsurance, we know is not an option. We found that by checking around and find

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

ng the best rates we were able to save a lot of money each year on premiums.

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

But we also found that you need to make sure you know what is covered and und

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

Professional from academic institutions, pharmaceutical industries, health care indust

erstand those policies completely. This is why we found an expert to help us.

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

I certainly hope this article is of interest and that is has propelled thoug

.

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

ht. The goal is simple; to help you in your quest to be the best in 2007. I t

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

Companies that provide selfless information through particip

hank you for reading my many articles on diverse subjects, which interest you

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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