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Ever procrastinate? Who doesn’t!

I often find myself di

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

gging through piles of mail, e-mail, invoices, newspaper

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

Examples of combination products may in

and telephone messages when something more important 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.

waiting for my attention.

The thought of that ‘one BIG

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

thing’ weighs on my mind, gnawing at my sense of peace a

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

Combination pro

d calm.

Writing it on my ‘to-do list’ doesn’t help. Onl

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

y doing it gets it done. And oh! – the surge of energy 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

d relief that accompanies completion!

Key Learning Poin

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

t

When you stop procrastinating and start doing, you re

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

ease the energy you need to get other things done. (You

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

eel better, too.)

Action Steps

This month, pick ‘one B

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

Following aspects would a

IG thing’ to improve the service you provide. Choose one

dd to the challenges in developing combination products:

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

big thing you’ve known about for some time – one that si

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

ts in the back of your mind, gnawing away at your peace

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

nd calm.

Maybe it’s updating your website, revising a p

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

ocedure, creating a customer appreciation campaign. Perh

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

Professional from academic institutions, pharmaceutical industries, health care indust

aps it’s upgrading your skills, teaching your team, reso

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

ving issues that need attention.

Whatever it is: you kn

.

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

ow what it is. It’s the one BIG thing that needs you. Th

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

Companies that provide selfless information through particip

se things must be done eventually. Make eventually today

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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