Advice Pool - Self Improvement

Spring is in the air and I can tell, know how? The air is warming up, the trees are turning green, and then there’s the restlessness I feel inside of me. It happens every year, and it’s one of the reasons springtime is a favorite of m

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

ine.

This restlessness makes me want to try new things, and create change in some way. It makes me realize that I’m tired of the same old stuff in my life, that what I want is newness. How does this manifest in my life? It starts wi

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

Examples of combination products may in

th a stirring. One that comes from deep inside of me. One that leads me to…clean out the clutter in my home. I call it my “De-Clutter Flutter” and it gets the whole ball rolling.

Before I go any further, a word about me. I’m not a

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

clean freak, though I often wish I were. I don’t have that organizer gene, though I think it would do me some good if I did. I am more of a Call To Action cleaner. I wait until I’m called and then I act. Spring usually brings the ca

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

ll and when it does I feel a remarkably strong drive that I can’t put off for one more day. I have to clean. Nothing else matters. I’m tired of all the #%$#*&# in my house!

And so it begins. Picking my first target, I approach the

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

Combination pro

closet door and, just as I’m about to open it, I stop and take a deep breath in order to just “be” with my feelings of total overwhelm. Yes, they too are part of my process. It’s then that I hear a little voice inside me saying, “Just

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

close the door, it’s been this way for years, why clean it now? Who cares, no one’s going to see it with the door closed, anyway!” And just when that voice is starting to make a real play for its point, I get tough and override it wit

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

, “I care! I know it’s here. I don’t like it anymore and I’m going in!” But right before I do, I think to myself, “I should probably call someone and let them know so they can send in the St. Bernard’s if I’m not out in a couple of da

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

ys, I mean hours.” And in I go!

In no time at all I’m taking everything out. From top to bottom everything comes out and lands on the floor, or what used to resemble a floor. It’s at this point that I start finding things that I hav

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

en’t seen in such a long time, I had forgotten about them. Many times I’ll think, “Why on earth have I held on to this? I don’t need this.” And out it goes. When I’m at this stage, it feels so good to toss out stuff I’ve been hanging o

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

n to for so long and for no reason.

Occasionally, I’ll find something I really do like but I forgot that I had it or where I put it. These little goodies get collected; I put them in a place where now I’ll remember that I have them, an

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

Following aspects would a

d where I can see them.

As I get to the end there are some very large garbage bags filled with the all junk I no longer need, want or feel the urge to save. Out go the big bags into the trash or the recycling bin.

I stand there and r

dd to the challenges in developing combination products:

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

eward myself with a long look into the closet. Now that it’s completely cleaned out I notice its lovely bareness. It now contains only what I really want and truly need. A deep sigh escapes me, relief in the job that’s done and pride

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

in what I see. And I think, “Why did I leave it this way for so long, I should have done this sooner.”

Every year, when I come to this point in the process, I notice something else…a remarkable change in my mental and emotional state,

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

I feel happy, lighter, freer. Not only is my closet decluttered, but my mind is, too. Maybe that’s the real reason I love spring so much-- once I get started, my external work soon is mirrored in my internal work. The same little voi

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

ce that originally told me to let go of the #$&*& in my home, is now telling me to do the same thing in my mind. Time to bid adieu to those beliefs and thoughts that have never served me and have never had a real purpose in my life. A

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd just like the junk I collected in my closets, these thoughts and beliefs are just junk taking up space, not helping me move forward and not helping me be happy.

The process of cleaning my closets is just the physical manifestation o

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

f the work I’m doing inside. It’s the time that I find myself taking “inventory” of what’s going on in my mind (as well as my home.) Clearing out my mind in this way is so important. It’s allowing me to make room for new possibiliti

.

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

es and opportunities to enter my life. In the same way that I look out my windows when spring comes and I see nature in all of its freshness and budding hope…inside of me I feel that same hope, freshness and possibilities about my life

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

Companies that provide selfless information through particip

.

You know the old saying, “Out with the old, in with new.” It’s true. But you have to clear out the old before you can have the new, whether it’s a new thought, belief, opportunity or material possession. I believe my soul knows that

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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