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Reports are coming from all over the country that we are in the driest period in over one hundred years. It does not matter which part of the country y

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

ou go to, lakes and ponds and streams are drying up at a record pace. What is the cause and how can we fix it?

It’s time to wake up and admit to our m

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

Examples of combination products may in

stakes. I’m talking about “Global Warming” and it is not just talk. If it were just talk, then how is it that the Polar bears are dieing at record nu

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

mbers? How is it that Penguins are disappearing off the face of the earth? How is it that Honey Bees are simply just vanishing?

Polar bears, though n

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

t too many know a lot about them are loosing their land at record pace. Reports indicate that as the ice cap continues to melt and shifts break off larg

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

Combination pro

pieces of the glaciers, this separates the Polar Bear from the connected land and while trying to swim to the “New Shore”, they drown.

With the warmin

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

g of the planet, there is a seasonal shift in the polar regions. This seasonal shift is throwing off the migration patterns of the penguins and thus, r

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

production is all but eliminated. Penguins are confused and are not reproducing at normal intervals, thus less young which could mean the end of that s

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

pecies.

Here is one that baffles even the most intelligent scientist. The all important Honey Bee is disappearing at alarming rates all over the count

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

y. Hives are simply vanishing. There are no signs of them dying off, but they are not producing honey and are not anywhere to be found. This can and

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

ore than likely cripple all fruit harvests in the coming future.

Honey Bees are important in the pollination process, which is essential for the crops

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

Following aspects would a

to produce each and every year. Without pollination, these crops will not produce as much and therefore from what I can see, can eventually stop produc

dd to the challenges in developing combination products:

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

ng all together.

It’s time to wake up to this “Global Warming”. It’s not fiction and it is happening right before our eyes. Everyone needs to do thei

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

r part in energy conservation, and not in a year or two from now, or when it is convenient. We need to seriously focus on the world we are going to lea

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

e our children.

Think about all the changes that have happened in your lifetime. Some pretty cool stuff have been invented. If we continue to disrega

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

d this true and undeniable situation, all that cool stuff, our toys, will not mean a thing. There will come a day when we will not be able to go outsid

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

Professional from academic institutions, pharmaceutical industries, health care indust

e without special glasses to block the damaging sun from burning our eyes. We will have to wear protective suits to protect from the radiation cause th

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

re is no more O-Zone layer. Or we will not be able to go outside at all anymore.

Everyone do your part. If you ask yourself what you can do, it’s the

.

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

little things. All little things make a difference. If you have a small trip to the store, say 5 miles o r so, take an electric scooter. Don’t waste

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

Companies that provide selfless information through particip

gas on short trips. If you look at it, a few short trips will actually pay for your scooter and you will be doing your part to preserve the environment

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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