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Businesses these days are stifled with inefficiencies brought on by bad legislation and brain dead regulators. But businesses have a choice; we have a way to fight the system. One way is to stop pro

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

ducing, raise prices and invest in better markets with higher returns and less regulation. As a matter of fact this is what many businesses do and are doing.

Look at all the off shoring of jobs and

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

Examples of combination products may in

factories in other countries by US based corporations. Why are they doing this? Because it just makes no sense to beat your head against the wall with over regulation, Sarbox and folks like Elliot

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

Spitzer with his extortion tactics. Recently someone wanted to buy a franchise from our company in California. He writes us and puts on the email address title; “RE; Franchise Opportunity” even thou

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

gh there was no first email from this gentleman and he then states:

“I'm interested in buying a franchise for the San Diego, CA market. Please send along any pertinent information I may need, alon

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

Combination pro

with information regarding "exclusivity" arrangements. I've never owned a franchise, but I have owned and operated any number of businesses over the years.”

We email him back:

“We are not sellin

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

g franchises anymore in Southern California and as a matter of fact we are setting up units in San Diego right now. This business is too good to share profits with franchisees in So. Cal. Especially

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

in such a litigious state. California just is not worthy of the incredible advantage franchising brings to the consumer and local economies. We would rather exploit the labor and take the money for

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

ourselves and remove those monies to other places more worthy of investment from a free market standpoint. That is what all the companies do. Can't blame them. I know you understand.”

Now mind you

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

in his first email he said he had owned and operated a number of businesses over the years. Yet, if this were true he would understand exactly what we were talking about; but instead we get back th

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

s email.

“No, I do not "understand. But if this isn't a joke, I will say this: You sound like one of the biggest assholes I've ever encountered in my entire life. And you can take your business an

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

Following aspects would a

d shove it up your ass...I can always outfit a truck and do the same thing. I also suggest you take a course in business ethics, professionalism...and some psychological counseling appears to be in

dd to the challenges in developing combination products:

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

order. Blow me.”

Now then either this guy is a complete competitor or a government regulator trying to pull some sort of entrapment scheme. Either way anyone who had been in business before underst

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

ands how ridiculous the over regulation is in this current period, especially in California. If he is a regulator he got upset for me telling the truth and felt belittled. If he was a competitor, he

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

simply wanted free information and was never going to buy anything anyway even if we were selling franchises there.

There is nothing unethical about making the most money you can on your invested

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

ollar and nothing wrong with investing your money where you can make the most return on investment. There is nothing wrong with teaching society, civilizations, nations or government regulators the

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

Professional from academic institutions, pharmaceutical industries, health care indust

truth about where they are leading this nation. There is nothing wrong with winning markets or being an entrepreneur. There is nothing unethical about stating the truth about bad legislation, over r

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

egulation or outrageous litigation. If some people cannot handle a little Ayn Rand psychology to help enlighten them, they have no hope indeed.

Apparently this poser or misrepresentation of a franc

.

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

hise inquiry cannot handle truth. Can you? Are you willing to take a hard look at your business and the over regulation and traps of litigation? Is it really worth the hassle? Ever wonder why so man

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

Companies that provide selfless information through particip

y businesses could care less about service anymore, raise their prices or just retire early and stop producing those things you as a consumer desire? Do you? Go read some Ayn Rand and think about it

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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Corporation incorporated for businesses engaged in charitable, religious, scientific or educational activities profiting for the betterment of the society is defined as non profit corporations.

The CNC router machine cuts in three directions at once. The precision of the router’s cutting relies on the design software, software that provides a two-fold advantage to the router operator. To begin with, the CAD software gives the operator of the CNC router machine the ability to create the design that will be cut into the solid plate.

Successfully selling your business, at a price and on terms that will allow you to maintain lifestyle, involves planning and discipline. John Reddish, a veteran of the process, shows you 10 Steps to Success that will give you the best chance for getting the right terms and the right price for you.

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