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Christmas, Hanukkah, Kwanza, Winter Solstice, many more traditions both religious and secular – all together, all at once the mere thought of it fills me with feelings of dread.

Is it because I rememb

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

er that winter in New York and how depressed that year was? Is it because there’s so much family at the holidays – and I feel not only obligated and exhausted but an adolescent again around so

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

Examples of combination products may in

much of my history?

My family history is wonderful. I’m one of the very lucky ones. A not so dysfunctional home – perhaps not passion, but at least humor, affection and lots of support and attention

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

for my brother and me. Perhaps it just feels as if all the pain of the world comes into relief around the ever present pictures of joy at this time of year. I know it’s not about me at all. It’s not p

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

ersonal. Do we all just notice, suddenly, all at the same time, that we’re all in this together? We go to church, go to synagogue, light candles, wrap presents, shop in the same stores, rush around in

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

Combination pro

the dark after work. It feels so unreal. Like going through the motions without any real heart.

And then all at once it hits me. It’s transition time. Something has ended. Something has started. Eve

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

n more than at birthday time, I’m older. My daughter moves toward her own life. My husband feels time – there are days to Christmas and days to New Year’s. We’ve done this before. Over and over. The ri

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

ual of transition.

To those of you who are waiting on the edge of a new relationship showing up or hoping the one you’ve started will turn concrete or hoping the one you’ve been long committed to wil

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

l take flight into bliss – believe it will. Regardless of how unsettling the holidays can be for so many reasons unique to each of us – there’s magic in the air. Things can happen. We are all teetering

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

at a transition, looking for meaning to drop into our lives. Allow it to tip in. It will.

Part of what is so challenging about the end of the year is that we all feel pressed to do so much.

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

Presents, parties, family, gather that man under your wing before the year ends, tension, anger, old resentments. Instead, try something different. Instead of trying to swim through this, sink into it.

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

Following aspects would a

Believe the wave of emotion and giddiness and pressure and pain and feeling like a child again will hold you up. You will not be dropped on your head. You will float across the sea of possibilities in

dd to the challenges in developing combination products:

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

to the next part of your life a bit more transparent. A bit wiser, a bit more vulnerable, feeling fragile but relying on the steel within you to let the world see what a beautiful, delicate, intricate,

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

complex and yet totally whole woman you are.

Even when I can’t see it, can’t feel it, can’t trust it, I believe. Sometimes I’m propelled into action to help someone else – and then I feel more human

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

nd less fragile. I feel of use. But sometimes I just make myself lie down on the floor and look up at the ceiling. Instead of a solid plaster barrier above my head – if I look really hard – I can see 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

window, a passage, a worm hole-time warp-incomprehensible path to what I can’t see. And it’s not just my future, it’s my possibilities. I look up into something I can’t see and let myself sink into my

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

Professional from academic institutions, pharmaceutical industries, health care indust

self. I thank the floor for holding me up, and then I just fly into whatever there is out there. I believe it’s bliss. I believe that my future and my daughter’s future, and my husband’s future, and th

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

e futures of all my dear friends and family and clients, and even the futures of people I can never feel close to or even good when I’m around them, are full of possibilities. Things I could never even

.

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

imagine. It’ll take the living of it, moment by moment, transition by transition, feeling by feeling, experience by experience, with the highest hopes I can muster, to discover what they are.

Wishing

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

Companies that provide selfless information through particip

you bliss, joy, experience, love, faith, hope, adventure, and a glimpse of the beauty of your own soul in a random moment shared with all of us in the place we can’t see that’s full of possibilities..

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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