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If you run a business opportunity business, you might be interested in the new proposed rules that the Feder

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

al Trade Commission is considering. It is important for you of course to protect your interests and advise 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

e FTC where they are so sadly mistaken or where they are absolutely correct in their assumptions. This helps

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

streamline the implementation of rules and regulations, which you will have to live with in the future. Spea

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

now or forever hold your peace as they say. The FTC States in their public announcement;

“The Commission i

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

Combination pro

vites interested parties to submit data, views, and arguments on the proposed Business Opportunity Rule and,

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

specifically, on the questions set forth in Section K of this notice. The comment period will remain open un

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

til June 16, 2006. To the extent practicable, all comments will be available on the public record and placed

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

on the Commission’s website:

http://www.ftc.gov/os/publiccomments.htm

After the close of the comment perio

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

, the record will remain open until July 7, 2006, for rebuttal comments. If necessary, the Commission also w

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

ll hold hearings with cross-examination and post-hearing rebuttal submissions, as specified in Section 18(c)

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

Following aspects would a

of the FTC Act, 15 U.S.C. 57a(c). Parties who request a hearing must file a comment in response to this noti

dd to the challenges in developing combination products:

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

e and a statement explaining why they believe a hearing is warranted, how they would participate in a hearin

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

, and a summary of their expected testimony, on or before June 16, 2006. Parties testifying at a hearing may

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

be subject to cross-examination.”

You can submit your comments to the via electronic system in a word file

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

from your computer or mail in your response, but you should now that there appear to be restrictions and add

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

Professional from academic institutions, pharmaceutical industries, health care indust

tional disclosure rules that will soon apply to your Biz Op in the future and thus you need to know what tho

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

e are going to be.

Additionally if you have a problem with any of the Blob of Bureaucracy’s proposals for c

.

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

anges you need to have your voice heard because some of this legislation could in fact shut your company dow

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

Companies that provide selfless information through particip

or cost you so much in legal fees to comply that you cannot remain profitable. So 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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There is a question which is sometimes asked by those new to the financial markets, and even occasionally debated by experienced participants. That question is how one differentiates between trading and investing. Because both trading and investing - when one considers them from the perspective of the financial markets - are performed in very similar fashions, they are often thought of as interchangeable actions.

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