Advice Pool - Reference and Education

If we are to send troops into a foreign land and the enemy uses biological wea

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

pons to attack our troops, then we will need to defend against this and protec

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

Examples of combination products may in

the human bio systems of each and every soldier. But we also have to worry a

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

bout the abatement of bacteria and the problems that bio warfare combat compou

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

ds, chemicals and biological contaminants contain.

For instance even if the s

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

Combination pro

oldiers put on their special gas masks and suits, this does not mean 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

acteria or biological contaminant or chemical is not all over the vehicles and

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

equipment and that must all be cleaned too. Additionally after the war and a

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

ter the enemy has been defeated the pollution problems of biological warfare w

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

ould remain for the inhabitants and citizen living in that area.

And even if

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

e did not as a nation use biological warfare, indeed if the enemy has been def

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

Following aspects would a

ated we will be left to clean up and therefore we need specific protocols and

dd to the challenges in developing combination products:

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

procedures and robotic equipment to help us with the abatement of bacteria and

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

biological contaminants which remain. This is very similar to our duties and

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

responsibilities and integrity of our nation the United States of America to c

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

ean up the land mines, which were planted in a war that may have been used aga

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

Professional from academic institutions, pharmaceutical industries, health care indust

inst us.

It is the right thing to do even if the enemy was wrong for doing it

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

as someone has to clean up. I hope you will please consider this in 2006. W

.

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 must allocate research and development dollars to protect the citizens of al

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

Companies that provide selfless information through particip

nations from left over biological warfare contaminants. 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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