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I wrote my first article in 1992 for a newsletter for the local psychiatric center and 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

was on helping parents deal with teenagers. Then I wrote another one for them on stress.

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

Examples of combination products may in

Now this was done by the guy who never finished his Ph.D. in marriage and family and the

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

apy because I believed I couldn’t write. So in ’94, I noticed an ad in the paper, the loc

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

l paper, they were asking again for people to submit articles for a weekly mental health

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

Combination pro

olumn.

Now there’d been three people doing it before and the gig was for six months to a

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

year. The three people before would write just wonderfully compelling and creative titles

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

like What is Manic Depression or What is Bipolar Disorder. Snore.

I applied, sent in th

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

two articles I’d written and got turned down. I came in second. What made it even worse

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

as someone in my practice got number one and then she proceeded to write wonderfully titl

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

d articles like, what is obsessive compulsive disorder following that same vein. A year l

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

Following aspects would a

ter the newspaper opened the column back up again. I got accepted and my first thought wa

dd to the challenges in developing combination products:

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

oh great, now I’ve got to come up with something once a week and then I thought well it’

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

only for six months to a year. Well six months went by and they were still wanting me to

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

do and somewhere in that first six months it got picked up by the parent company and syn

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

icated all over the country and all over the world and a year went by and they still want

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

Professional from academic institutions, pharmaceutical industries, health care indust

d me to do it and here we are thirteen years later and they’re still wanting me to do it.

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

I tell you this story not to impress you but to impress upon you the importance of find

.

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

ng a way to get started. Even if you do not believe you can write, like I did.

Pick a pl

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

Companies that provide selfless information through particip

ce to start. You never know where your article writing and marketing is going to take you

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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