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In response to what is now being called the Black Sunday riots in Lebanon, a massive turnout of people has gathered in Beirut

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

for Tuesday, February 14, and is being widely supported across the United States. This event also launches the one-month per

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

Examples of combination products may in

od of remembrance for last year’s Cedar Revolution. Events which had already been planned for Tuesday’s one-year anniversary

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

of the assassination of former Prime Minister Rafik Hariri have been adapted into a march for peace in Lebanon. In the U.S.,

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

hree million Americans of Lebanese descent are rallying to support this small, Middle Eastern country which still has emotion

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

Combination pro

l ties for their families, according to Sanford Holst, chairman of the Hariri-Tueni Remembrance Committee.

The Black Sunday

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

riots broke out on February 5 in Beirut when Muslim protesters attacked the Danish mission and a church. It brought back unwa

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

ted reminders of the civil war which ripped Lebanon apart from 1975 to 1990. The peace rally on Tuesday is seen as an antidot

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

to these heightened tensions. It will be held in Martyrs’ Square, the same place an estimated one million people gathered la

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

st year in the now-famous Cedar Revolution.

In the U.S., urgent activities are under way to allow millions of Americans of L

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

banese descent to join the Beirut proceedings by telephone or online at www.cedar-lebanon.com. Many are also joining Lebanese

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

Following aspects would a

American clubs across the country to continue the peace effort through the full month of remembrance which lasts until March

dd to the challenges in developing combination products:

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

14.

President Bush, in pointed reference to the perceived instigator of Lebanon’s recent troubles, called for Lebanon to be

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

free of Syrian intimidation, free to chart its own course." Of the 174 people arrested in the Black Sunday riots, 76 were Syr

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

an, 38 were Lebanese, 35 were Palestinian and 25 were stateless Bedouins.

"Lebanese people in the USA and in Lebanon are ups

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

et by these events, but also hopeful that peace will prevail," said Holst. "Historically the Lebanese have always been peacef

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

Professional from academic institutions, pharmaceutical industries, health care indust

l until outside forces provoked violence."

Sources:
"Bush Orders Full Probe of Hariri Murder" (Reuters 1/27/06)
"

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

ally, Concert to Mark Anniversary of Hariri’s Murder" (Daily Star [Lebanon] 2/4/06)
"Beirut Rioters Attack Church" (Lo

.

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

s Angeles Times 2/6/06)
"Beirut Mob Burns Danish Mission Building Over Cartoons" (New York Times 2/6/06)
"Are Extr

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

Companies that provide selfless information through particip

mists Fanning Cartoon Outrage?" (AP 2/9/06)
"Siniora Unites Country’s Religious Leaders" (Daily Star [Lebanon] 2/11/06

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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