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A father of two daughters, I am blessed with joy, laughter and tears brought by these little angels. I once h

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

ad someone told me,” We don’t ‘make’ our children, we merely received them from the Creator.” That made me 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

ink about the new responsibilities I will now have to oblige!

Life in the modern times of fast pace and dema

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

nding changes is by no means easy for working mothers, as they try to balance work and time with the closest

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

thing in their new life - their baby. Whether you are a single mother or otherwise, it does demands good time

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

Combination pro

management, and a great deal of energy to keep up with the work and family. For the many mothers who has or i

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

s going through this, would understand.

Time spent away from the child, does harbors concerns beyond the mon

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

ey factor, like welfare of the child, psychological and physical well being. Also, thinks of the things that

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

they could be missing, their baby’s first word, the first step…things that will only come once our life time,

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

those sweet valuable moments.

The sacrifices many working mothers made are the most noble, in my view, stri

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

ing to improve the quality of live for their family. The need for financial stability and independence is obv

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

Following aspects would a

ious, but so are the solutions available to help these women achieve a “best of the both world”. One can now

dd to the challenges in developing combination products:

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

have the opportunity to work from home, with the help of technologies. A revolutionary industry has sprung up

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

all across the world in the form of the Internet. This has been proven to help many mothers stay at home whi

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

le they make unbelievable amount of money on line. The new found knowledge has help many women achieve financ

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

al success, sometimes even over shadowing their male counter part or spouse. The ingrained motherly nature ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

tually makes a woman more focused and committed to realize their goals. Such is the portrayal of the power of

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

Motherly Love, to protect and defend its young.

Humans adapts, in the new world, there will naturally be ne

.

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

w ways to make money, be it full or part time. But the duties and cycle of life is ancient and unchanged. So,

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

Companies that provide selfless information through particip

working mothers, you can be also be staying at home to enjoy the “best of both worlds”.

Ataneh (Anthony Tan

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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