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There is a new trend in political correctness in relation to Christmas. Around the world there are calls to down play Chri

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

stmas so not to offend other denominations. However has it gone too far? In Australia the Prime Minister, Mr John Howard

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

Examples of combination products may in

has advocated publicly for shopping centers to restore nativity scenes. Many centers have removed them in fear of being tar

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

eted by other religions as being offensive in the now multicultural society.

Christmas has a strong heritage in Australia,

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

America and many other countries around the world and is a strong part of the cultural history in these lands. Today argum

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

Combination pro

nts have surfaced all over the world calling for Christmas to be banned from public places in order not to offend people of

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

other faiths or non-believers. There are many who now believe Christmas should be down-played.

It was recently reported on

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

the television in Australia that one school Principal wrote a letter of apology to one angry parent after the word "Christm

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

s" appeared in the school newsletter. Other schools have stopped singing Christmas carols while others have no Christmas di

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

plays so not to offend other denominations. Where is the democracy and right to free speech with all this fear being relaye

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

about a long lived community event? Australian's shouldn't have to apologize for their heritage or celebrations. It's par

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

Following aspects would a

t of Australia's history and culture and it's the countries principal faith. Political correctness does not need to go mad!

dd to the challenges in developing combination products:

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

After all Christmas is a time where the community and all people of all faiths are invited to come together in joyous celeb

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

ations.

In Australia the Prime Minister, Mr Howard has come out in strong defense passionately upholding the right for rel

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

gion at Christmas saying it's part of the Australian way of life. Australian's have a long history of celebrating Christmas

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

which includes a live telecast of ‘Carols by Candlelight' seen throughout the nation as one of the most popular and joyous

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

Professional from academic institutions, pharmaceutical industries, health care indust

elevision events of the year. In the USA The White House has on it's site the reading of Christmas stories by political fi

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

ures and partners upholding and celebrating demonstratively the support of Christmas.

Long live Christmas and let's rememb

.

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

r its real meaning. It's a time to forget our differences and find common ground. A time to display the symbolic meaning of

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

Companies that provide selfless information through particip

Christmas: unity, peace, forgiveness, love, celebration of life and the extended hand of friendship to all in our community

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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Compassionate men and women who suffered through the decade long national agony of Vietnam now have deja vu nightmares that come from the ruthless narcissism of reactionary politicians, mega-rich plutocrats and fundamental preachers.

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