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If you are fed up with the United Nations, you might consider supporting the new United Nations of Freedom Project based in Colorado Springs, Colorado. A country must demonst

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

rate a commitment to freedom to be eligible for membership. This highlights the problem with the United Nations, any country can join and the UN's mission does not acknowled

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

Examples of combination products may in

ge that without economic, political and religious freedom, there can be no lasting peace, security or sustained economic progress.

The United Nations is a flawed institution

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

primarily because of its nebulous mission and lack of membership criteria. The United Nations of Freedom Project is an organization with the clear mission of promoting freedo

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

m and a rigorous membership criterion.

Here is the language in the United Nations Charter Article 4, Chapter 2, which applies to membership.

“Membership in the United Natio

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

Combination pro

ns is open to all peace-loving states which accept the obligations of the Charter and, in the judgment of the Organization, are willing and able to carry out these obligation

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

.

The admission of any such State to membership in the United Nations will be effected by a decision of the General Assembly upon the recommendation of the Security Council.

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

”

Of the 192 current member countries, more than 70 do not have a democratic form of government and the group of G-77 votes as a bloc and easily mobilizes majorities to bloc

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

k reforms in the General Assembly and other U.N. bodies.

It has become a dysfunctional organization that the late Daniel Patrick Moynihan, former U.S. Ambassador to the Unit

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

d Nations described as “A theater of the absurd, a decomposing corpse, and an insane asylum.” Another U.S. Ambassador to the United Nations Jeanne Kirkpatrick commented that

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

“Rather frequently, what goes on in the U.N. actually exacerbates conflicts rather than tending to resolve them.”

The purpose of the new United Nations of Freedom Project is

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

Following aspects would a

to “encourage economic, political and religious freedom in the world by recognizing countries that respect and protect these freedoms."

Membership in the United Nations of

dd to the challenges in developing combination products:

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

reedom Project is earned by demonstrating a commitment to freedom in the following areas: a democratic form of government, freedom of religion, rule of law and an independent

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

judiciary, freedom of speech and the press, and economic freedoms such as free competitive private markets.

To judge commitment and progress to economic freedom, the United

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

Nations of Freedom will rely on the Heritage Foundation/Wall Street Journal Index of Economic Freedom established a set of objective economic criteria that has been used for

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

the last ten years to study and grade various countries for the annual publication of the Index of Economic Freedom.

There are 192 member countries in the U.N. and it has 59

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

Professional from academic institutions, pharmaceutical industries, health care indust

,000 employees. The U.S contributes $1.3 billion annually. The United Nations of Freedom has 57 member countries with a current annual budget of $125,000.

The initial goals

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

of the United Nations of Freedom Project are to build support for an alternative organization dedicated to freedom, monitor the progress of countries in implementing reforms

.

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

hich increase freedom, highlight in the global media the connection between freedom, opportunity, economic growth and prosperity, and support other like-minded organizations

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

Companies that provide selfless information through particip

dedicated to increasing freedom around the world.

The United Nations of Freedom Project is sponsored by ChartwellAmerica. For further information, please call 1-877-221-1496

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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