Advice You - Business

There is no sector of the U.S. Economy that is more vital, yet often ignored' than small business sector. While many thought that big business dr

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

ove the U. S. Economy by virtue of employment and the ability to produce products at lower prices, that is not necessarily the case. While we are

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

Examples of combination products may in

currently appalled and angry at the excess of some of the biggest businesses, the fraud and destruction of many employees' life savings and the l

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

arge number of cutbacks in employment of these companies, the small business sector continues to make its mighty contribution to our economy. A b

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

tter measure is that out of almost 5 million corporations in the U.S. there are less than a million corporations with annual revenues of more tha

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

Combination pro

a million dollars. More than 80% of all corporations can be considered small business. They employ 51% of all public sector workers and represen

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

t nearly all of the self-employed, which makes up about 7% of the civilian workforce. In the face of the wide layoffs caused by the current marke

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

disruptions, the small business sector still provides about 75% of the net new jobs.

The small business sector also makes a large contribution

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

o federal government activities, capturing about one third of all prime and subcontract dollars.

In Texas the story is much the same. There are

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

almost 400,000 employer businesses and over 98% have fewer than 500 employees. Small business employment represented 47.6% of the states total em

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

loyment according to the U. S. Department of Commerce. In 2000, the non-farmers proprietors' share of small business income totaled $68.1 billion

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

Following aspects would a

and increase of 7.2% over 1999, a remarkable performance indeed.

In June of 1998, the office of Advocacy for the Small Business Administration i

dd to the challenges in developing combination products:

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

ssued a report entitled; "The New American Evolution -The Role and Impact of Small Firms." In it they state that in addition to statistics on inc

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

me and employment, the small business sector contributes mightily in two major ways.

"They are sources of constant experimentation and innovatio

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

, they are an integral part of the renewal process that defines market economics" and secondly "by creating opportunities for women, minorities 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

nd immigrants, they are an essential mechanism by which millions enter the economic and social mainstream."

Nowhere is this more evident than in

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

Professional from academic institutions, pharmaceutical industries, health care indust

the Houston Metropolitan area.

All of you, sole proprietors, home based business owners, LLC's and sub-S corporations, retailers, wholesalers, m

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

nufactures, importers and exporters, professionals, tradesmen and all others engaged in small business; this is your opportunity, during this per

.

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

iod of business malaise, to stand tall with full appreciation for the tremendous contribution you are making to your country, the economy and you

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

Companies that provide selfless information through particip

employees as well as yourselves.

Never has the small business sector been more important and each of you should take pride in your contribution

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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Businesses are unpredictable beasts a once successful company can quickly find itself in financial mire. When a company has to tighten its belt, redundancy is often on the cards.

Your opportunity to build a stellar client relationship starts with managing the gap between your perception of how things are going and your client's. Begin the process here . . .

A one to three page simple business plan. To define your business idea and answer the questions you need to ask before starting your business.

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Advice You - In Praise Of Entreprenuers

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