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The baby is learning how to walk. It’s so amazing to watch. I was always under the impression that one fate

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

ful day, the baby would suddenly throw aside the plastic bag or hanger or whatever they were playing with,

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

Examples of combination products may in

get a glimmer in their eye, and then rise up as if being pulled by puppet strings. Then they would begin to

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

move forward, haltingly at first, but then with gusto.

I’ve come to realize, as with most things, that it

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

’s really so much more subtle than all that.

One day I noticed that she was watching everyone and their me

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

Combination pro

thods of transportation. Some people moved very quickly, with large steps and others - those closer to her

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

size - moved slower and with smaller steps. She started moving along furniture, amazed by what those two le

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

s of hers could do. Still, crawling was much more efficient.

But then she started to indicate that she wan

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

ted to “practice walking.” When Nick got home from work she would crawl to him and pull herself up on his l

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

egs. He would then hold her hands as she walked around the room. This was very exciting to her; whole new w

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

orlds were opening, as well as new levels to explore.

Then one day, she was “practicing” her walking and N

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

Following aspects would a

ick had her balanced, standing all by herself. At that point, she took several steps forward into his arms.

dd to the challenges in developing combination products:

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

Both he and I erupted into cheers and clapping. She just looked at us like she had no idea what was going

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

on - this was obviously something she had been working on for some time - where had we been all along?!

Si

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

ce then, she’s been walking more and more steps each day - with more and more assuredness each time. There

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

was no real distinct moment where she suddenly threw off her proverbial shackles and chains and started ski

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

Professional from academic institutions, pharmaceutical industries, health care indust

pping through the house.

And I guess my point with this whole thing is that everything seems to be more su

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

btle than we think it should be. Everything is changing constantly and new ideas are coming to fruition whi

.

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

le old ones are dying. This is the way of life. Generally, there is no sudden awareness; there is only our

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

Companies that provide selfless information through particip

day-to-day struggle. But once in awhile, we’ll get a little glimmer and we’ll start to take some baby steps

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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