Summary - Relationships

Let me tell you a little about the Gossip Mill.

It is a universal machine, churning out gobs of useless and time-consu

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

ming drama for nearly every individual on a never-ending basis. From coast to coast, on both sides of the globe, you ca

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

Examples of combination products may in

find it. Comprised of thoughts and flesh, words and dress, it is the largest working organism on the planet, and it ne

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

ver fails to deliver. Though its parts may often differ, all the way from ethnicity to age to religion, it is without d

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

ubt a human construct. Animals do not engage in such frivolity. Their time is understandably better spent putting all o

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

Combination pro

f themselves into enjoying the finer things in life – eating, sleeping, sex. Completely uncomplicated.

No, The Gossip

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

ill cannot work in the Animal Kingdom, as such unabashedness would serve as the ultimate monkey wrench, completely dism

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

antling the entire thing, with no hope of ever being repaired. The Gossip Mill needs conniving minds and chattering mou

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

hs; it needs elaboration, exaggeration and iteration. Above all, it requires the rabid craving to openly analyze and cr

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

iticize its own individual working parts behind their backs. This is both the very function and purpose of the machine,

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

all in one, and how amazingly human it is.

I know. It’s a Catch 22. It’s a staggeringly defeating, depressing waste of

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

Following aspects would a

time, but you are a part of it. Don’t believe me? Think about your last conversation, or the one before that. Think ab

dd to the challenges in developing combination products:

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

ut your friends, your acquaintances and lovers. You’re there – we all are. The Gossip Mill is one of the greatest machi

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

nes the Grand Illusion has ever come up with, simply because it is so amazingly self-sufficient. No outside maintenance

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

is required – we, the parts, give it all the lube it needs, and how soundly we do sleep.

Getting sick of it? Tired of

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

being of being a company man? Feel you’re half-awake already and ready to make that leap? So go pull a Thoreau

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

Professional from academic institutions, pharmaceutical industries, health care indust

then. Wander deep into the woods, alone, and find what your own mind has to offer. See how long you can last. Chances a

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

re you’ll come screaming back before the clock strikes twelve, weeping and blubbering, kissing the sweet, grimy floor o

.

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

the Gossip Mill and taking up that uniform with a demented new verve and gleam to your eye. The Animals don’t need you

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

Companies that provide selfless information through particip

. The Gossip Mill does.

“Don’t just call me pessimist. Try and read between the lines.” – Maynard James Keena

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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