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As a fan of both the classical and the modern, I interchange between both. However

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

I believe there are certain times when each has its place - and I have to say tha

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

Examples of combination products may in

t today I decided eCards suck at Christmas!

Here's 7 reasons why:

They

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

're lazy. [They say… “I was in a hurry, and forgot to get you a real card.”]

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

They're cheap. [They say… “You're not worth a couple of dollars for a card an

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

Combination pro

d a stamp.”]

They get blocked by email spam filters. [Oh joy!]

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

>They're impersonal. [Nothing says “Your special” like a handwritten eCard. It jus

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

t warms the heart doesn’t it?]

They require the reader to work for your

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

“special gift.” ‘Dear Bob, Simply visit our online eCard store to download your eC

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

ard [number 898323232423] using pass code TRX46546'.” Golly, just thinking about l

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

ogging onto yet another online retail store to be bombarded by promotional message

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

Following aspects would a

s while trying to find my “special gift” just makes feel so festive!

The

dd to the challenges in developing combination products:

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

y're temporary. And who wants to print out their eCard on the office laser printer

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

anyway? Whoever said that ‘Toner Black’ is the new green & red was seriously dist

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

urbed! [My wife likes to put our Christmas cards on display to show friends how po

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

pular we are ;) Just try that with an eCard!]

And lastly… Email is 'quic

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

Professional from academic institutions, pharmaceutical industries, health care indust

k' and 'convenient' - Christmas cards shouldn't be...Take a moment a show someone

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

you really care.

And if you’ve missed the mail, just pickup the phon

.

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

e and call them instead. At this time of year you should connect… AND DON’T YOU DA

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

Companies that provide selfless information through particip

RE LEAVE VOICEMAIL!

Happy Christmas... and YES... I did send real cards this year

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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