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Many parents and teachers are concerned about cutbacks in funding for foreign language programs at the elementary school level.

Is there anything a parent can d

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

o to support early childhood language education in their communities?

Yes! I recently attended a presentation given by Janis Jensen, the NJ Coordinator of World

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

Examples of combination products may in

Languages and the President of the National Network for Early Language Learning. During her talk, she made these suggestions for parents and teachers who are be

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

ng faced with potential cutbacks in their school's foreign language programs.

1. Be an advocate. Many of the teachers at the presentation agreed that act

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

ive and vocal parents can play a very influential role (sometimes more than teachers) in convincing school boards to support funding for early language learning.

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

Combination pro

Consider organizing concerned parents, and presenting a compelling case to the school board for maintaining adequate funding for early language learning. Sendin

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

articles to the local newspaper about the benefits of early language learning also can help generate support for funding language programs.

2. Stay informed

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

. To make a case to administrators, you must clearly state the benefits of early foreign language education. Research has shown cognitive, academic, and soci

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

al benefits to early language learning. Furthermore, the nation as a whole benefits from developing kids who have a global understanding and can communicate with

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

people from other countries and cultures. You can learn more by visiting the website of the National Network for Early Language Learning (www.NNELL.org).

If yo

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

u are concerned that language programs in your school are being cut or are substandard, find out if your school is meeting state standards. You can find out more

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

Following aspects would a

about your state's world languages standards by going to the Department of Education website for your state.

3. Consider alternatives. You may want your

dd to the challenges in developing combination products:

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

school to offer a great Spanish program, but keep in mind that the specific language offered is less important than the opportunity for the child to learn ANY fo

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

reign language.

Note that the Bush administration recently announced a National Security Language Initiative to increase the number of Americans who can speak w

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

hat they deem to be “critical” languages (e.g. Chinese, Korean, Hindi, Arabic). Recognizing the need to start teaching these languages in the Pre-K and elementar

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

level, the government is offering funding for schools to offer programs in these critical languages. If funding constraints are keeping your school from offerin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g a quality program, suggest they develop a program in one of these critical languages, utilizing the federal government's new grants. One such grant is through

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

the Department of Education's Foreign Language Assistance Program (FLAP) and provides incentives for teaching critical need languages in K-12. $24M has been earm

.

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

rked for these grants. For more information on the FLAP grants, go to the following website for funding updates (click on Chart 1): http://www.ed.gov/fund/grant/

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

Companies that provide selfless information through particip

find/edlite-forecast.html.

With active advocacy on the part of informed parents, there are many opportunities to support robust early language learning programs

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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