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Over the past decade, music has been severely declining within the California schools. A recent study showed that within the past five years there

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

has been a 50 percent decline in student participation in music programs. Additionally, it showed that one third of all music teachers have lost th

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

Examples of combination products may in

eir jobs within that same time frame. The study predicts that music education will be eliminated from the California schools within the next ten ye

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

ars, unless dramatic changes occur. Music within the California schools system is at a critical juncture.

Singer Bonnie Raitt said, “It’s a shame

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

we are depriving so many California children of the benefits of music in schools.” She stated that every child deserves the chance to develop their

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

Combination pro

fullest with a well-rounded education, including the arts.

To that end, the California Arts Council spearheaded the California Music Project (CMP

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

), a 401(c)(3) nonprofit, long-term initiative. The California schools, music industry executives, and the council will work together through 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

CMP to bring much needed revenues and music programs back into the California schools. The goals of the CMP are to:

• Provide grant funding to mus

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

ic teachers, music professionals, and the California schools to bring more music leaning to students;
• Develop joint ventures with universiti

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

es, businesses, foundations and music-focused organizations to fund, pilot and expand music programs within the California schools; and
• Serv

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

as an advocate to both the public and private sectors to further music as a core discipline, so that every California schools students has equal a

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

Following aspects would a

ccess.

Governor Arnold Schwarzenegger proposed and approved a state budget with the California schools slated to receive an estimated $105 million

dd to the challenges in developing combination products:

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

in ongoing funding for arts education. That is an estimated $17-18 per student. Included is a one-time allocation of $500 million for arts, music

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

and physical education equipment. Yet, it will not be enough to reverse the tremendous, almost ten-year decline of music education within the Calif

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

ornia schools. The California schools remain underfunded and understaffed in music education.

The CMP plans to heighten awareness and raise funds

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

through all-star music CDs with top California performers, special events, and concerts around the state.

The first CD is scheduled for release in

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

Professional from academic institutions, pharmaceutical industries, health care indust

late October. Artists, publishers and labels donate all the songs and performances, with proceeds going to the CMP. It features a variety of genre

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

s from 18 California singers, musicians and bands. Included are: Los Lobos, Leela James, Beck, Dwight Yoakam, Warrne Zevon, Ben Harper, Jack Johnso

.

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

n, Jackson Browne, Bonnie Raitt, the Red Hot Chili Peppers, and others.

The artists are very passionate about their work and want to see Californi

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

Companies that provide selfless information through particip

a schools students get some of the same attention they received while growing up around music. Working with the CMP, the artists may get their wish

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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