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The recently signed deal on Nuclear Assistance between India and USA is a huge failure of President Bush to tackle the real nuclear threats that we face. Bush has done what his all predecessors even his own father refused to do - bre

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

ak the US and international law to aid India's nuclear-weapons program. The deal was cooked by a handful of senior officials and never reviewed by the departments of State, Defense or Energy before it was announced. Congress was neve

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

Examples of combination products may in

r consulted. This appears to be another give away to a foreign government and corporate interest of personal friends of President Bush and Vice President Cheney at the expense of US national-security interests. Underlying the Bush ad

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

ministration’s strategic embrace of India is the “democratic peace theory”—the premise that democracies don’t go to war with each other. In fact, the nation with by far the most military interventions since World War II has been a li

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

beral democracy—the United States. The only hope is now to see that the US Congress would be able to block the deal. Given the bilateral nature of the deal, Pakistan could have a similar arrangement with China and we can see another

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

Combination pro

Nuclear Arms race in subcontinent.

Technology, Internet and the development of science has made the world a better and a smaller place today. The pace of evolving technology has made us more interconnected and interdependent for ne

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

eds of commerce, trade and eventually for our survival. The last 2 decades have seen unprecedented development and the next few will bring in something we cannot foresee today. In this world of constructive development, it is very im

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

ortant and relevant that our governments make decisions that are more constructive and do well not only to their own citizens but to all mankind. Human race has been seem to be most co-operative and communicative in face of earth sha

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

ttering disasters and mishaps, which gives rise to more hope. In view of these facts, it is very important that all governments and leaders listen to the common voices of their people, instead to taking partial and myopic steps espec

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

ially in regard to issues as important as nuclear weapons and wars.

On Nuclear Weapons, all mankind, as one, has taken a decision to eradicate them. So on what grounds do our governments can decide against the will of their people?

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

The decision by President Bush to get into a treaty with Indian government will be laying the ground work for another arms race as a perilous affair as far as the future of the world is concerned. The Non-Proliferation Treaty (NPT) s

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

Following aspects would a

ignatories and US Congress will need to react to this quickly and effectively remembering their obligations to the future generation and to the whole world community to decommission all nuclear weapons and make the world a safer plac

dd to the challenges in developing combination products:

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

e. The beginning of another nuclear arms race, perpetrated by the Bush Administration will only increase the risk of proliferation in the near future, which will leave an endangered legacy to our children and grandchildren, if we are

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

not already doing so, by appending valuable money towards the development of weapons of mass destruction instead of elevating the downtrodden. The responsibility of any and all our governments is not limited only to their citizens,

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

ut to humanity as a whole.

American people and US Congress needs to do a little soul searching in light of President Bush’s announcement of the deal with India. As a sole surviving super power, is America taking care of the good of

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 world? Is it fulfilling its responsibilities as a sole super power? Is it setting the right precedent to other nations, ethically and morally? Is it telling the world, that a country can break international laws at its whims and

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

Professional from academic institutions, pharmaceutical industries, health care indust

fancies? America is fighting terrorism, but is it not creating an environment suitable for fighting terrorism through its lopsided foreign policy? Is America making the world a better place or a more dangerous place to live in?

Ever

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

y human being on the planet has a right to be free from poverty and fear… especially the fear of nuclear weapons. Can the recourses allocated towards creating a nuclear arsenal be diverted and used to create better facilities for hea

.

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

lth care, shelter and education in addition to the providing the basic amenities and necessities that facilitate normal, dignified human life for everyone?

I am of the firm and unshakeable belief that every human being has the right

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

Companies that provide selfless information through particip

to a nuclear free existence and in asserting the same we can safely affirm that we have chosen to lead our lives together, as one big human family and friends, and not be foolish enough to die together because of a nuclear holocaust

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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