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Many fishermen are quite disgusted that they are not allowed to catch certain types o

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

f fish certain times of the year and although they understand the law they often thin

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

Examples of combination products may in

k it is rather ridiculous because they only wish to catch a couple fish to eat. Where

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

as they say that the commercial fishermen catch scores of fish of the same type and a

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

l they want is a couple of fish.

Indeed it makes sense, that things are done the way

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

Combination pro

they are but it is hard to justify for the single fishermen all these incessant rule

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

s from the Fish and game. It is for that reason that the Fish and Game Departments ne

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

ed to spend time and energy in crafting a strategic public relations program and fish

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

rmen community goodwill program.

The Department of Fish and Game should also be very

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

careful to keep in constant contact with all media outlets in order to educate and e

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

xplain to the public why the rules are the way they are. Research and studies into t

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

Following aspects would a

he ecosystem and environment should also be abbreviated in articles that are mass dis

dd to the challenges in developing combination products:

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

ributed out to the public by the Fish and game.

There is no easy way to keep everyon

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

e happy all the time and fishermen just wanna go out and catch a few fish although so

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

metimes, yet sometimes they too will abuse the privilege. If fishermen catch fish th

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

at are too small and too many of them they can cause problems and cause the fish to g

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

Professional from academic institutions, pharmaceutical industries, health care indust

extinct in a lake or in the ocean area near where they live.

Studies and research i

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

nto the local ecosystem regarding the fish can give us a better idea of what is going

.

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

on and how best to strengthen the policies. All this should be promoted as positive

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

Companies that provide selfless information through particip

public relations for the Fish and Game and I hope 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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