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How far does your service go? And how much farther can you stretch it?

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

If you serve customers, do you stretch to do it better every day? Are

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

Examples of combination products may in

ou eager to learn from colleagues and mentors, seminars, books, website

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

, and a healthy dose of candid customer feedback?

If you provide inter

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

nal service, do you reach across functional lines, or stay stuck inside

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

Combination pro

your departmental 'silo'? Is your communication with colleagues and par

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

ners positive, proactive and persistent?

If you serve in your communit

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

y, do you volunteer time and stretch a little more by asking others to

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

oin you?

If you serve your family, do you reach out with a higher leve

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 attention and affection every day?

If you serve the planet, are yo

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

ecologically aware? Do your actions inspire and educate the neighbors?

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

Following aspects would a

If you serve humanity, do you cultivate true compassion, patience, ki

dd to the challenges in developing combination products:

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

dness, respect and encouragement of others?

If you serve all life, hav

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

you expanded your sense of life itself and your understanding of what

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

it means, being here 'in service'?

Key Learning Point

Service is a gr

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

at line of work, and those of us who do it daily are certainly among th

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

Professional from academic institutions, pharmaceutical industries, health care indust

fortunate on Earth. You can increase your good fortune, and that of ot

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

hers, by deepening your commitment and expanding the impact of your ser

.

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

ice every day.

Action Steps

Make an extra effort to s-t-r-e-t-c-h you

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

Companies that provide selfless information through particip

sense of service. Each day, offer a little more than you did yesterday

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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