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On a recent trip to Canada, I was stopped at the border, before entering the United States. Security directed me to a building where

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 stood in line. Everyone looked as confused as I felt, and I tried not to panic. To late! First the hot flash came out of no wher

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

Examples of combination products may in

. I had this vision of my companion being given permission to cross the border in my car, leaving without me.

I started to fidget un

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

omfortably, when this little old lady patted me on my shoulder and said, "Don't worry Dearie." "Just don't say anything." "They wil

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

keep you here for anything." "Just suck it up." With a weak smile on my face, I took her advice. One hour later, I approached the

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

Combination pro

esk. The woman, who looked like a drill sargeant, said, "You will need a passport the next time you travel." Looking puzzled, I sai

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

, "But I entered Canada with only my naturalization papers and driver's license and I had no problem."

She stamped my papers, and lo

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

udly announced, "next" without looking up. I made my appointment to obtain my passport. The room was packed with people, all speak

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

ng in different languages at the same time, when this man entered the room. He had shoulder length black hair, a black coat, down to

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

is ankles, and was carrying a long suitcase, with a belt wrapped around it. He abruptly stopped in the middle of the room, looked ar

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

und with shifty eyes, and started to babble, waving his arms above his head. Watching him pace back and forth, I couldn't make out i

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

Following aspects would a

he had to use the bathroom or if he was just agitated.

Finally, security directed him to the immigration window. As I witnessed th

dd to the challenges in developing combination products:

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

s scenario, I went into a laughing jag. I tried to contain myself, worried that he might notice me. I found a magazine and started

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

o leaf through it mindlessly. "Never know what he might be carrying in that suitcase," I thought. My number was finally called. I ap

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

proached the man at the window, and was told that the forms I so carefully filled out, were outdated. Then he proceeded to tell me m

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

photographs were unacceptable. "You smiled and your teeth are visible," he said. I looked at this man in dismay and said, "Well, I

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

Professional from academic institutions, pharmaceutical industries, health care indust

would have taken them out, but those teeth are mine!" "You'll just have to come back again," he said impatiently.

As I stepped into

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

the elevator, I became claustrophobic. We were jammed in like a bunch of sardines. It was hot, odors were stifling, and the elevato

.

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

creaked. Stopping on all floors, three more people got on board. I saw the capacity sign on my left, and I thought, "Oh my God, we

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

Companies that provide selfless information through particip

are all going to die!" Finally, the door opened on the ground floor, and I thought, "I am so looking forward to my next appointment.

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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