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So often online we find ourselves in a debate perhaps in an email corre

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

spondence or in an online forum or Blog. As the debate rages on, the ot

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

Examples of combination products may in

er parties will try to pull a fast one and use some statement which is

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

quite absurd, but relatively hard to prove. Eventually if you call them

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

on their comments they merely accuse you of being something evil. And w

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

Combination pro

hether you are or are not you could not prove it either way.

You canno

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

prove you didn't kick your dog, even if you do not or have never had a

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

dog, you cannot prove that either. So the debates just spiral and spin

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

out of control all the while the other party pretends to take the moral

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

and logical high-ground? But are they really using logic or did they m

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

rely take a course in rhetoric in the past?

My favorite logic fallacy

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

Following aspects would a

s when someone starts giving me statistics to prove a point which have

dd to the challenges in developing combination products:

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

nothing to do with the question and are relatively meaningless. The one

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

I think is funny is the statistics that the average person has one boob

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

- statistically correct, but about the most worthless information in t

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

e universe.

Still, the reason people use such rhetoric and fallacies i

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

Professional from academic institutions, pharmaceutical industries, health care indust

n logic in debate or in online forums is because of the average intelli

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

ence of the readers, in other words as bad as some of these fallacies i

.

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

n logic are, they often work and that is the scary thought. Folks need

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

Companies that provide selfless information through particip

o be smarter than this and understand what is going on when they see it

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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