Advice You - Business

I always carry my PDA with me when I go anywhere. I use it to upd

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

ate any calendar dates on the go. If someone asks if I am free at

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

Examples of combination products may in

some point in time, I do not trust my memory as quite often I end

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

up double-booking myself. I have learned the hard way. I went to

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

big event in the city not too long ago. I was there to meet with

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

Combination pro

an important client and to also meet this client's spouse. They

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

sked if my husband and I could attend a celebration of the fastes

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

growing businesses in the area. The time and date were given to

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

s and we said we would be there. When I finally looked at my cale

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

ndar, we were double booked. The second meeting was for a family

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

irthday.

Now we did not know what to do. If I missed the client'

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

Following aspects would a

celebration, I would likely lose out on a potentially good contr

dd to the challenges in developing combination products:

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

ct. If I missed the birthday, I would be in trouble with my famil

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

y. I almost decided to be sick that day. As it turned out, the fa

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

ily birthday celebration was changed to another day in the week 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

d I was able to attend both. I learned my lesson; never say yes u

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

Professional from academic institutions, pharmaceutical industries, health care indust

til you know for sure that you can make the event.

If you do say

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

yes to an event, make sure you show up. Nothing is worse than ag

.

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

eeing to something and not following-through. You will gain more

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

Companies that provide selfless information through particip

ith the business relationship by doing what you said you would do

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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