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I spent months wondering if my new partner was secretly married.

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

The turmoil that I went through trying to figure it all out was

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

Examples of combination products may in

he worst time of my life. Should you just come out with it or ju

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

t stay quiet? Confront them or let it go?

My own advice to anyo

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

e is “If you suspect it – act on it!” There are some pretty obvi

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

Combination pro

ous signs like still wearing a wedding ring and claiming that the

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

can't get it off, or, it would upset the children too much!

Ask

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

them the same questions about their life over a two week period.

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

If someone is lying they will soon slip up, and trying to hide an

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

other family will result in them spinning a huge lie. The more c

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

mplicated the lie, the easier it will be for them to slip up.

Yo

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

Following aspects would a

can spend thousands on a Private Investigator to try and track h

dd to the challenges in developing combination products:

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

m down and build a report on what they are up to when they are no

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

t with you. This can soon mount up as they charge by the hour.

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

ou also have no guarantee that any results will come your way.

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

is whole process can leave you stressed, exhausted and down right

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

Professional from academic institutions, pharmaceutical industries, health care indust

fed up. Suffering will soon send you round the bend and drive a

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

wedge between you and what could be a genuine partner. Or you co

.

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

ld be letting them get away with cheating on you. Don't suffer a

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

Companies that provide selfless information through particip

ymore - take action today and stop the suffering once and for all

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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