Useful Advices - Business

The Federal Trade Commission is considering a new proposed rule, which would require

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

Biz Op's and business opportunities to substantiate earnings claims that they may t

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

Examples of combination products may in

potential buyers if the buyer requests them. Such earnings claims proof will hopefu

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

ly eliminate much of the fraud that goes on in the business opportunity sector.

Bel

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

w is a copy of the Federal Trade Commission's proposed rule on substantiate earnings

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

Combination pro

claims to potential buyers to ask for them;

Proposed section 437.5(f): Written subs

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

antiation for earnings claims

“Proposed section 437.5(f) would prohibit a seller wh

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

makes an earnings claim from failing to provide written substantiation to prospecti

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

e purchasers and to the Commission upon request. Rather than mandating that business

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

opportunity sellers include documentation for earnings claims – which could be volum

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

nous – in the earnings claim statement itself, section 437.5(f) would reduce complia

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

Following aspects would a

ce costs by requiring only that such materials be provided to potential purchasers a

dd to the challenges in developing combination products:

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

d to the Commission upon request. Purchasers could then review the documentation if

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

hey so choose.”

Most business opportunity practitioners are indeed honest, however

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

any simply make up huge numbers that the buyer may potentially make if they buy the

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

usiness opportunity. For instance; “Make $10,000 per month stuffing envelopes part-t

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

Professional from academic institutions, pharmaceutical industries, health care indust

me in your own home, while working in your underwear and watching TV.” You may think

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

this sounds funny and indeed it is, however now the business opportunity practitione

.

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

s would have to come up with names and proof that people were actually making that k

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

Companies that provide selfless information through particip

nd of money after they had bought their business opportunity. Consider 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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Useful Advices - Biz Ops and Business Opportunities Must Substantiate Earnings Claims

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