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Having been involved in the franchising industry I have seen a lot of well-i

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

ntentioned advertisements that simply did not pull and often I would cringe

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

Examples of combination products may in

hen I looked at some of those ads. But it was not just our franchise company

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

franchisees that needed help, truly it is most all small business people.

W

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

e finally instituted a plan that our franchisees had to fax us a copy of the

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

Combination pro

r ad 24-hours prior to sending in for publication, if they did not hear back

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

from us in 12-hours it was automatically approved. The turn around had to be

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

fast, as we did not want our franchisees to miss a deadline or marketing op

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

ortunity and we know people wait until the last minute. Also we wanted sales

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

and for them to make money as that is the goal in business.

That first year

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

we rejected about 50% of the advertising display type ads and radio blurbs.

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

Following aspects would a

A funny thing happened by not too unpredictable. You see the franchisees wou

dd to the challenges in developing combination products:

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

d send fax in the ads on Saturday night at 10 PM hoping we would not see the

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

and they would be automatically approved for fear we might reject them at H

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

Q. It was obvious we needed some help here. So, we revised the advertising i

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

our Confidential Operations Manuals.

Still we had to consider regional var

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation and ads do not work the same everywhere you see. So, as a small busine

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

ss person you might wish to consider doing it right and perhaps hiring a pro

.

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

essional Yellow page advertising lay-out, design and strategist, indeed that

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

Companies that provide selfless information through particip

is something most small businesses can use. Please consider all this in 2006

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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