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New Orleans is one of the most exciting cities I have visited. My girl

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

friend and I took a week-long trip there in April, 2003. We stayed in

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

Examples of combination products may in

renovated old hotel in the French Quarter. The food and music are fan

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

astic and the old architecture is quite interesting.

While in the Big

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

Easy, we heard the Preservation Hall jazz band perform twice. They wer

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

Combination pro

terrific! They played in a very old hall and we had to stand for an h

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

our to watch them, but it was well worth it. We also heard much jazz i

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

other clubs as well as on the street, mainly Bourbon Street, which is

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

well-known for its wild, partying night life.

We loved the food in Ne

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

Orleans. Our favorite restaurant was Deanie's, which is well-known fo

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

its spicy seafood. We went there four times. We ate crawfish etouffe,

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

Following aspects would a

which nearly burned our mouths off. We also had some great shrimp po-

dd to the challenges in developing combination products:

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

oys. We also attended a cooking school, in which they showed us how to

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

make several southern dishes including gumbo, jambalaya, and bread pud

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

ing. We bought the ingredients before leaving and I have used their re

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

ipe to cook gumbo a few times since, which came out great!

Another th

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing to do around New Orleans is to take daily outings through the bayo

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

country. We took a couple. One day we took a boat along a river, past

.

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

some small crocodiles. Although it was raining, we still had a great t

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

Companies that provide selfless information through particip

me. We visited some old Cajun and Creole plantations on another outing

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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