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Do you plan meetings or conferences in Canada or Mexico that U.S. citizens attend

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

? If so, you may soon have a tough time picking the perfect location for your ne

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

Examples of combination products may in

xt meeting or conference when a new effort by the Department of Homeland Security

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

is implemented in December 2006. Called the Western Hemisphere Travel Initiative

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

(or WHTI referred to as “Wheaty”), this effort requires all travelers entering o

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

Combination pro

r exiting the U.S. from the Caribbean, Bermuda, Panama, Mexico and Canada to have

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

a valid passport or other secure travel documentation. Beginning in December 200

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

7, the requirement extends to all land border crossings.

Changes may be coming t

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

o WHTI – several senators have filed WHTI–related pieces of legislation that may

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

extend the 2007 date. At the World Travel and Tourism Summit in Washington, D.C.

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

n April 11, Homeland Security Secretary Michael Chertoff spoke about an alternate

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

Following aspects would a

to the passport called the People Access Security Service or PASS system. This w

dd to the challenges in developing combination products:

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

ould allow travelers to satisfy the WHTI mandate with something more convenient a

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

nd cost-effective than a passport – a type of identification card similar to a dr

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

iver’s license. There are also plans to combine all individual traveler programs

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

into one global enrollment system.

It is not clear what the future holds for WHT

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

Professional from academic institutions, pharmaceutical industries, health care indust

I and border security concerns, but it is something that planners need to keep in

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

mind while selecting site locations. When the changes do go into effect, be sure

.

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

to let your attendees know what the new requirements are and any changes that ma

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

Companies that provide selfless information through particip

y occur. For more information on WHTI, visit the Department of Homeland Security

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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Taxpayers should guard against tax scams through tax filing season. Toward the end of the filing season, however things often get worse.

Long-term care insurance policies have a variety of features and it pays to shop around. It is quite easy in the final years of your life to run up extremely large care bills which could threaten your life savings, home and your children’s inheritance.

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