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It was more than a decade ago when I created the lyrics to a rap song " Stop Cri

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

me Against Kids." Now, as the children are older, and the crime in our schools a

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

Examples of combination products may in

nd communities keeps getting worse, money is needed to provide more protection for ou

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

children.

There is amazing interest from parents and communities in a project that

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

will do more than just create awareness. The project needed is massive and money is n

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

Combination pro

eded to fund police protection and for protective equipment in our schools. Action is

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

needed now and the communities are invited to participate.

You might have watched t

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

e movie "Pay It Forward." A little boy came up with a big idea that would i

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

mpact may people's lives. You are invited to help "Stop Crime Against Kids."

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

Here's what you can do..

Take the lyrics to stop crime against kids and have kids i

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

n your schools or community sing them in a rap. Make a cd, get some community corpora

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

Following aspects would a

te sponsors and involve your local television stations. Get the kids on television si

dd to the challenges in developing combination products:

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

ging and make a cd for your community and schools.

Give each of the children who si

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

ng the "Stop Crime Against Kids " rap song a copy of the cd for their effor

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

s. Set a price for the cd and take all the money from the sale of the cds to bring mo

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

re police protection and safety equipment into your schools and community.

You have

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

Professional from academic institutions, pharmaceutical industries, health care indust

ll help and support we can give you to help your children. The good news is that if y

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

ou do this with a group of children this year, you can have another group of children

.

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

make a cd next year and keep up the process of raising money to make our schools safe

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

Companies that provide selfless information through particip

r. My thoughts and prayers go out to all of the children and families in this country

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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