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All parents want what is best for their children. We want to instill in them the ability to make sounds choices and grow into happy and productive adults. Da

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

n Kindlon, PH.D author of Too much of a Good Thing: Raising Children of Character in an Indulgent Age says that children build self-esteem by overcoming obst

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

Examples of combination products may in

cles. When parents shelter their children they deny them the opportunity to make mistakes and to learn and grow from experience. Children will make important

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

decisions for themselves, whether we prepare them, or not.

For our children to become the adults we envision, we need to allow them the opportunities in yo

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

th to learn about life and how to make decisions that are best for them or in their interest, not ours. This decision making opportunity comes at a very youn

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

Combination pro

age. Mac Bledsoe, author of Parenting with Dignity believes that by the time a child is 9 years old they should be making 50% of their own decisions. This m

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

eans that a 3 year old child should be given some decision making opportunities such as a choice in what to eat for snack, or in what to wear, but not when 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

go to bed. The idea is that by the age of 9 our “mortgage” with our children is half paid. By the time they are 18 years old we want them to be able to make

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

smart decisions for themselves, as our mortgage with them should be paid in full.

The home is one place we can let go of some controls. For example we can i

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

ncrease our child’s independence and ability to handle responsibility by having our children do chores. There are numerous benefits to the routine of chores.

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

There are times that education, guidance, or supervision is required but it is also important to let them figure some stuff out for themselves. Allowing chi

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

Following aspects would a

dren to determine how they will get their tasks done provides an opportunity for problem solving while allowing them to take an active role in the care and u

dd to the challenges in developing combination products:

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

pkeep of their immediate community, their home. It is important for parents to resist the urge to redo their child’s work efforts. When we redo something, we

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

need to think about the disempowering message sent to the person who has just spent their time and energy on a task. Is that the message we want to give?

To

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

ay children are SO busy with activities and homework that we often find it easier to let them off the hook with their chores. Our rationalization is that the

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

y can get their homework done sooner so they can actually have some free time to play. As important as down time is, it does a disservice to our children whe

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

Professional from academic institutions, pharmaceutical industries, health care indust

we let these things slide. Responsibilities in the home provide an opportunity for developing self-discipline and learning problem solving skills, while con

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

ributing to the care of the home.

Simple chore charts are great reminders for what needs to be done and decreases our need to remind, or nag as they would s

.

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

ay. Asking what needs to be done rather than reminding them what needs to be done allows children to think about things and places the responsibility for tas

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

Companies that provide selfless information through particip

s back on them. Creating an environment where our children can safely practice sound decision making will prepare them for making wise choices in the future

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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