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We are all aware of some of the nasty spills the Cruise Ship lines ha

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

ve taken with negative public relations and much of it is undeserved.

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

Examples of combination products may in

Nevertheless crisis management is a part of Cruise Ship line Public R

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

lations, just as much as positive public relations and travel industr

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

goodwill.

Perhaps you'll recall two years ago the outbreak of a vir

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

Combination pro

us on a cruise ship line and another cruise ship, which had bacteria

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

n the water. Neither of these were the actual cruise ships fault. B

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

t rather they had picked up water and a port, which was not good.

Th

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

same thing happens on airliners when they fill up with water and for

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

eign airports. There was another problem recently where a newlywed h

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

sband got into a fight and ended up overboard and no one had ever see

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

Following aspects would a

him again. His widow and their family sued the Cruise line and made

dd to the challenges in developing combination products:

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

a huge issue out of it.

Cruise ship lines have to overcome negative

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

public relations and crisis management of this type and be careful to

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

promote positive public relations all year round, otherwise they cann

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

t fill up the ships with passengers.

Public relations for Cruise shi

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

Professional from academic institutions, pharmaceutical industries, health care indust

lines means they must also keep up communication lines with all mass

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

media outlets and promote all the good things they do such as assist

.

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

ng during the Indonesia tsunami efforts and the post hurricane Katrin

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

Companies that provide selfless information through particip

disaster relief efforts. Perhaps you will consider all this in 2006

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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