Main Subject - Business

Don’t forgive the people who haven’t supported you in the past.

Tha

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

t’s right – you read correctly. I don’t want you to forgive them.

I

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

Examples of combination products may in

want you to thank them.

Every day, in my head, I thank the people

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

who said I wouldn’t be able to start my first business at age 15. Ev

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

ery day I thank the people who thought I would fail opening a real e

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

Combination pro

state agency at 21.

When people expect you to fail or don’t support

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

your endeavours you can do two things. You can believe them. Or you

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

can show them. I know which I chose to do. What’s your choice going

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

to be?

I chose to use their negativity as fuel for my energy and d

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

rive. I used their words as motivation when I was feeling low. I dec

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

ded that success was the best and only form of revenge I would ever

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

Following aspects would a

enact on these people.

In life you are always going to encounter ne

dd to the challenges in developing combination products:

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

gative people. If you don’t meet these negative people you will neve

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

r know the following:

How much you should love and apprec

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

iate the positive and supportive people in your life

How good

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

you’re going to feel by becoming successful and proving them wrong

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

Professional from academic institutions, pharmaceutical industries, health care indust

You can get angry, you can try and get even – OR you can get

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

on with it and become an unequivocal success. Two options will get

.

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

you tired, probably bitter and will usually prove the doubters right

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

Companies that provide selfless information through particip

.

Remember – Success is the only acceptable form of revenge.

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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Main Subject - Revenge the Right Way!

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