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What was becoming a major crisis is now over, as Veterans Administrat

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

ion gets the Laptop back, which had Personal Information on it of ove

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

Examples of combination products may in

26 million veterans. Luckily the stolen laptop was recovered, but ma

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

y I ask why the government has this information in the first place on

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

portable laptops?

And it is not just the Veterans Administration it

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

Combination pro

s all sorts of other agencies too. Identity Theft is running ramped a

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

nd the government is to protect the American People, yet if you look

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

t the situation it is the government who is messing up the most.

In

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

act the Identity Theft laws are to be enforced on businesses by the F

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

ederal Trade Commission, but the Federal Trade Commission lost two la

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

tops with over 100 names of individuals with social security numbers,

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

Following aspects would a

drivers licenses numbers, names and addresses on it, as well as perso

dd to the challenges in developing combination products:

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

nal financial records.

My Gosh this is the very agency required to h

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

lp protect the American People from Identity Thieves, but cannot even

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

protect them selves. How utterly pathetic, you have to be kidding me,

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

after all that hoopla and press releases and public relations campai

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns and they themselves fail to protect their own team at the Federal

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

rade Commission?

Folks we need a complete over haul of bureaucratic

.

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

BS in Washington DC. The problems with Identity Theft are the governm

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

Companies that provide selfless information through particip

nts fault, how can we trust them to protect us? Consider this in 2006

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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