Advice Pool - Reference and Education

In the past decade homeschooling, once a rare practice, has grown exponentially; currently

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

well over a million kids are being homeschooled in the U.S. From kindergarten children to

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

Examples of combination products may in

teenagers, kids are being educated in the home by parents who have access to an ever-grow

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

ing collection of instructional materials, both printed and online.

But with the growth o

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

f this phenomenon come worries about the social skills of these young people. Some homesch

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

Combination pro

ooled teenagers are reporting difficulty in relating to their contemporaries, while others

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

miss out on extracurricular activities like team sports, band and chorus activities, 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

other enrichment experiences.

Some parents have succeeded, either by persuasion or throu

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

gh the court system, in getting their children accepted into the extracurricular offerings

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

of their local school, while retaining their right to homeschool.

Homeschooled kids, by

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

ature of the at-home educational experience, spend much more time with one or both parents

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

Following aspects would a

than kids who attend public school. While this can undoubtedly be a valuable experience,

dd to the challenges in developing combination products:

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

it may also present problems when it comes time for maturing teens to develop increasing i

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

ndependence from their parents. In this instance, carefully supervised summer camps or tee

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

n wilderness adventures, without parents, can serve as an important bridge to a

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

"_new" href="http://www.outdoors.org/education/twa/index.cfm">homeschooled teen’s sen

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

Professional from academic institutions, pharmaceutical industries, health care indust

se of self separate from the family unit.

Homeschooling can be a wonderfully supportive e

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

xperience for young people, and with some understanding of a child’s need for outside soci

.

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

al connections and eventual self-actualization, opportunities can be provided that will m

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

Companies that provide selfless information through particip

inimize or eliminate the possible downside—a sense of isolation from the greater community

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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