Top Adding - Legal

As an Online Think Tank member, I know that there are two or more sides to every issues and different

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

perspectives and belief systems on all sides of any debate about right and wrong. Yet, I see internati

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

Examples of combination products may in

onal intellectual patent protection as a crisis that should have already been solved. The United State

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

s must seize this opportunity to fix the problems with our trading partners on the other side of the p

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

lanet.

Some say that in the future the US will design everything and the Chinese will make it all. Bu

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

Combination pro

t that is not really true and anyone who is watching the changes and trends can see it simply is not s

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

o. So what am I saying here?

What I am saying is two-fold;

1.) It is a fallacy to believe that every

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

thing will be designed by High-Tech in the US and then made in China; China and India for that matter

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

will both "design (and/or steal) and build" in the future. Therefore counting on high-tech or a knowle

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

dge society to propel the economy is a questionable strategy for the future.

2.) I agree that a knowl

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

edge society is smart either way, in that it makes sense to have more intelligent people making better

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

Following aspects would a

decisions and problem solving, rather than stuck in linear thoughts leading to dead-ends due to the l

dd to the challenges in developing combination products:

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

aws of unintended consequence perpetually peppered in Murphy's Law.

So, those are my thoughts. And ye

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

s, the keeping of secrets in the information age is totally out the window totally. Top Secret means t

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

wo-weeks basically. Confidential means one-email and Super Duper Top Secret is a Myth, heck it will be

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

in Aviation Leak and Spy Technology in the weekly online edition.

Besides in Eastern Culture they va

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

Professional from academic institutions, pharmaceutical industries, health care indust

lue friends and friends mean you share information and knowledge and if you do not share your knowledg

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

e with me, then obviously you are not my friend (their perspective). So the dilemma is dealing with th

.

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

e culture issues. Friends=Share Eastern VS. Business Partners=Friends Capital Western win/win culture.

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

Companies that provide selfless information through particip

I certainly hope that this article makes you think in 2007 and helps you in your quest to be the best

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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