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I apologize in advance, because the truth can hurt. But since it’s

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

also good for you, here goes:

No one wants to be a victim o

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

Examples of combination products may in

f a scam or illegal scheme.

If you don’t know any better, you

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

ll put the words “illegal” and “scam” together. There are illegal scam

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

s, but not all scams are illegal.

Have I lost my mind? No. I’ll

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

Combination pro

explain.

First, let’s agree on what a scam is. How about “impr

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

per conduct with the intention to cheat”? OK, that sounds like a good

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

definition. But is that “illegal”?

In multilevel marketing, 97%

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

of us who try to make money fail. If we’re lead to believe that we’ll

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

DEFINITELY make lots of money, that’s the “scam”. But it’s not necessa

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

rily ILLEGAL. A scam’s not illegal--- unless it breaks the law.

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

Following aspects would a

So the “get rich quick” lie in itself is not the problem; that

dd to the challenges in developing combination products:

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

s the American Dream. The problem happens when the Dream breaks the la

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

w.

MLM companies know that. Some of them go to a lot of trouble

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

to make an “opportunity” LEGAL. But if it’s designed for most of us t

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

fail, that is a scam.

Maybe the Dream you’re working on

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

Professional from academic institutions, pharmaceutical industries, health care indust

is the real deal. But it’s probably not. Con artists are more than qu

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

alified to make a scam legal. Legal and legitimate are two different t

.

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

ings.

Let’s summarize:

1. Most MLM companies are scams.<

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

Companies that provide selfless information through particip

br>2. Some scams are LEGAL.
3. SOME MLM companies are NOT scams.

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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When relocating to a new area, make sure to double and triple check the health care services in the area, especially if you are a retiree or you are in need of specialized medical services. Many hospital websites and chamber of commerce websites don't tell you the entire story about health care in specific areas.

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