Actual - Legal

The emergence of law goes back 10,000 years in Chinese History and we see 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 first true signs of the need for laws in advanced civilizations in the W

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

Examples of combination products may in

estern World in 2900 B.C. when a priest wrote that he was indeed upset with

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

the social ethics and complained to King Saneferu in letters.

He indicate

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

that the; "Lack of rules or law plundering was common and business conduct

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

Combination pro

ill-managed" was causing strife and civil unrest and that something had to

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

be done. We can only assume that if these letters indeed made it into the

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

ritten record of history that they were of concern and dealt with. Of cours

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

e once you make the first law or rule we all know what happens after that.

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

Today we have so many laws that lawyers cannot possibly know all the laws

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

r areas of industry sub-sectors that they control. Today our courts are bac

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

Following aspects would a

k-logged and even our police carry thick books with the vehicle codes so th

dd to the challenges in developing combination products:

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

ey can look up what to put on the Ticket. We know all this bureaucracy caus

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

es a severe hardship on everyone; from public servants to citizens.

Of cou

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

se as we see back in 2900 BC, Anarchy is no better, thus we should find som

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

e middle ground, keep our laws as simple as possible and not allow run away

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

Professional from academic institutions, pharmaceutical industries, health care indust

bureaucracy to impede the flows of our civilization or court system.

I ce

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

tainly hope this article is of interest and that is has propelled thought.

.

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

The goal is simple; to help you in your quest to be the best in 2007. I tha

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

Companies that provide selfless information through particip

nk you for reading my many articles on diverse subjects, which interest you

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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