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They say that Ignorance is no excuse for the law and yet many who break the law

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

use this as their first excuse? But Officer; I did not know that 90 mph in a sch

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

Examples of combination products may in

ool zone was illegal here? Yah, sure, step out of the car turn around and put yo

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

ur hands behind your back.

Recently an Online Think Tank took up this issues as

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

one member recalled a recent conversation about this very fact in which the oth

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

Combination pro

er party went into a near tirade about how ignorance was a reasonable excuse for

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

accidentally breaking the law. In fact, he stated;

Dear Sir, your comments abo

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

ut ignorance and the law are of interest in that the real problem is that things

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

like the Motor Vehicle Code, Building Codes, OSHA laws etc are so voluminous 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

at no one but an idiot savant could know them. The lawyers, policemen, judges, w

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

y they are forever looking it all up themselves. It is completely silly as so ma

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

Following aspects would a

ny of the laws get so out of control that they cross the lines of common sense.

dd to the challenges in developing combination products:

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

So, then you have applied your own common sense to the senseless over regulatio

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

n and rules I see. Which is fine, until human nature intercedes and someone desi

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

res what you have and uses those laws to stifle your best efforts. I hear what y

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

ou are saying there. Indeed, we need to have a "red magic market" committee to e

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

Professional from academic institutions, pharmaceutical industries, health care indust

liminate the complexity the crushes creativity and innovation out there.

Of cou

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

rse the debate rages on and so do the lawmakers and so the citizens are lost in

.

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

fear of breaking laws they have no clue about. In any case I certainly hope this

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

Companies that provide selfless information through particip

article was food for thought and of interest to you to propel your mind in 2007

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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Chemical or pharmaceutical industries obtain patents to protect their inventions. However, many of the patents do not hold up to intense scrutiny by lawyers and courts. This article provides practical tips for obtaining strong patent protection on inventions so that these industries can resist competition successfully.

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