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You know it seems to me having done much business with Arab Gentlemen that if you do not BS a little they re

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

ally do not respect you much, and the problem is that under US law you have to be truthful. They like to cat

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

Examples of combination products may in

h you in a tall tale, it makes them feel smart and then they BS back and everyone laughs and they say; “You

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

now I like you.”

It really is a cultural thing, it is not really lying it is more like creating falsehood 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

ter falsehood until everything is so G-darn convoluted you don't know what's up anymore. It is fun in a way

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

Combination pro

to negotiate like that, but it is nearly impossible for written contracts, because the negotiation really st

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

rts once you have already signed the agreement you see or once you have already been had by some rather intr

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

guing line of reason.

Next after signing an agreement they will of course hold you to your obligations, but

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

find convoluted reasons why they will not honor their obligations due to some other interesting made up misr

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

epresentation, embellishment and basically BS. But it is how they do it. It used to bug the crap out of me r

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

ally. Now I understand how it works it is kind of funny really? Most people get way uptight, I just laugh.

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

Following aspects would a

he problem is most Arab Business people are really okay once you get to know them, but they have scoundrels

dd to the challenges in developing combination products:

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

oo out to really stick it to you, like the scam artists in the western world. I guess every nation has their

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

fraudsters really. Those are the ones you need to watch out for, but once you learn who they are and deal w

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

th them appropriately it ain't all that bad. But check six.

In negotiating with Iran it is a much different

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

story. As Reagan use to say, "trust by verify" no matter who you negotiate with whether they pound their fis

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

Professional from academic institutions, pharmaceutical industries, health care indust

s on the table and mean it or whether they are just giving you a round of horse crap; “good guy, bad guy" yo

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

u see? It's all fun, but when you play at that level you cannot afford to lose so you keep the cards close t

.

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

the vest and if someone cheats, well shoot first and don't miss. I think that is what the Iran deal is comi

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

Companies that provide selfless information through particip

g down too really? Too bad the cultural differences so easily lead mankind to war. 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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