Advice You - Business

If you own your own independent business, there are two organizations that

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

hopefully your are already aware of. They are doing great work promoting sm

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

Examples of combination products may in

ll, locally owned independents by promoting community and government involv

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

ement. It takes all of us, working together, to improve our communities and

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

the local business environment.

The National Federation of Independent Bus

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

Combination pro

nesses helps individual business owners with planning, taxes, and legislati

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

ve matters. They have representatives in all 50 states and in D.C. I visit

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

heir site often for advice and articles. I guarantee that you will find sev

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

eral useful items of information within their site.

The American Independe

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

t Business Alliance, based in Bozeman, MT, promotes independents buy helpin

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

business owners form IBAs, or Independent Business Alliances. These allian

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

Following aspects would a

ces in turn promote community involvement, the best example being the annua

dd to the challenges in developing combination products:

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

America Unchained Day, which takes place every November, the Saturday befo

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

re Thanksgiving. They show their communites the power of "putting your mone

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

where your house is".

I urge all independent business owners to join NFIB

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

and look into starting an IBA. I am in the process of doing both. We need t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o team up for our communities and independent business owners.

Make a diff

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

rence as a consumer as well. You do have choices. A good place to start is

.

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

by watching Independent America, a documentary about a married couple searc

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

Companies that provide selfless information through particip

ing for Independent America and filming the results. It's a real eye-opener

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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