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What is it with Corporate America? When did they stop caring about t

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

he people that helped them reach the top? Was it a result of the gre

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

Examples of combination products may in

d-driven 80’s? Maybe after the whole country stopped smoking marijua

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

a they looked for an alternative high and found it lying in their wal

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

et.

No matter what the answer may be, we are living in a corporate h

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

Combination pro

man wasteland. Being out of school less than 10 years, I’ve already

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

een my share of corporate crimes against humanity. Outsourcing. Lay

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

ffs. Reorganization. Sound familiar? What happened to senior execu

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

ives? What happened to their conscience? Maybe their huge egos swal

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

owed it up.

If you’re one of the millions of people that I’m guessin

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

can relate to this rhetoric, stick around. I think you’ll find that

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

Following aspects would a

you’re not alone in this war we call “making a living.” Most of us s

dd to the challenges in developing combination products:

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

em to be stuck in these jobs with no way out. I'm here to tell you t

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

at there is an exit door if you're willing to put some time and effor

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

in to reach your goals.

My relief has come in the form of a home-ba

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

ed business. Having the ability to determine your own destiny has a

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

Professional from academic institutions, pharmaceutical industries, health care indust

uality to it that can't be described in just a few paragraphs. This

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

reedom is my goal to not only achieve myself but to help others to ac

.

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

ieve as well. The true joy comes in helping people find their freedo

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

Companies that provide selfless information through particip

and remembering that you can build a business that does have a heart

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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