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It is very important that you are respectful to the w

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

omen who are in attendance at the social. Many of the

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

Examples of combination products may in

have spent the equivalent of several months’ salary

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

or clothes, transportation, and lodging in order to b

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

there. Some may have traveled hundreds of kilometers

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

Combination pro

and a day or more in travel time to come.

I can ass

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

re you that most of the women in attendance are very

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

erious about being at the Social. With a ten to one r

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

tio of women to men, it is obvious that many of these

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

women will be disappointed. Please bear this in mind

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

The odds are stacked in your favor so that you are g

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

Following aspects would a

aranteed to win.

You have paid thousands of dollars

dd to the challenges in developing combination products:

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

or that privilege. But bear in mind that the women in

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

attendance have paid just as high a price based on t

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

eir personal resources as you have. In many ways they

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

have more to gain and lose than you do.

Consequently

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

Professional from academic institutions, pharmaceutical industries, health care indust

you should respect their time and level of commitmen

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

t to the social introduction process, as their happin

.

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

ss is as important to them as yours is to you. For th

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

Companies that provide selfless information through particip

se reasons, please show them all the courtesy you can

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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