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Bend over backwards to stand behind the name and make it known for service and custo

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

mer focus. Although this seems like common sense, it does not always happen that way

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

Examples of combination products may in

We as humans tend to look in other pastures to see what is greener and sometimes ac

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

ually move there. I was recently in a training class for a large corporation. This c

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

lass was teaching their channel partners how to use and install their world class so

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

Combination pro

tware.

The instructor was well versed with the ins and outs and overall had great e

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

perience with these classes. No one from the company had actually attended any of th

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

ese sessions in the past, so one or two of us decided to take part. It certainly was

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

an eye opener. We spent a fair amount of time bashing the company and saying what th

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

y should do to the product to make it work better. If that was not enough, he convin

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

ed a few participants to buy someone else's product. If he had backed up the company

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

Following aspects would a

and their name, he probably would be working today.

You must decide where

dd to the challenges in developing combination products:

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

you belong, do not complain about what is not right, do something about it. Stand be

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

ind the company and make it successful. After all, they are paying you for your serv

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

ices. When your contract gets down to complaining without action, it is definitely 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

me to move on. Just think of the saying "Are you IN or are you OUT". If you are IN t

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

Professional from academic institutions, pharmaceutical industries, health care indust

en back up the company and its name all the way. If not, move on to the next contrac

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

t.

A company's name gives them market recognition and even though you may

.

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

ot always agree with the way they do things, you should help them to gain more marke

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

Companies that provide selfless information through particip

share. Create a business relationship that shows you care about what they are doing

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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