Summary - News and Society

It is always funny when "third-world" news stories pop-up regarding outrageous differences in income. Sometimes one cannot believe the evil that occurs in mankind that would

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

allow such a thing to happen. Thus, revolution of a society is inevitable. We all know about places like Brazil, Venezuela or Colombia where the income disparity is nauseat

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

Examples of combination products may in

ng as well as the poverty factor. This always leads to socialist or communist governments to take hold. The USA is always somehow "in shock" when this happens.

This takes u

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

s to New York City, good old capitalist America. A couple of news stories coming out of of the city of late point to an increasingly distressing situation that puts the plac

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

in a bizarre world. First, word has come out that the cost-of-living for renters-not even to mention potential buyers-just keeps on going up. The latest reports have about

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

Combination pro

3% of renters spending at least 50% of their income on rent. In other words, nearly unlivable. Secondly, in an almost nightmarish story, recent New York City Police Departme

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

nt graduates have been applying for food stamps. Yes, food stamps! New York City's "Finest" are quickly becoming its poorest. These are the same people who make it possible

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

o have record amounts of tourists pouring into the city. Of course, when it comes to contract, the city just does not have the money. Uhhh... yeah right. Thus, new recruits

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

re coming in to the department making around $25,000 a year. In New York, that kind of money can't buy you a paper bag, forget an actual shot at the "American Dream."

The s

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

imple reality is this: Workers are just not cared about. The rich are always cared about. They make the rules, donate money to campaigns and pay people off. Lies that the ri

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

h will somehow "leave" the city if taxes are raised on them are comical. Where are these people going exactly? Meanwhile, the "working stiff" is being drilled into the groun

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

Following aspects would a

with assorted fees, taxes, adjustments, and simply not being able to keep up. Thus, stress, tension, anger and a never-ending obsession with money become the ways of life.

dd to the challenges in developing combination products:

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

Walk by any group of people talking on a corner in NYC and you will hear a financial conversation in about 70% of the chats. What about sex? What about vacation talk? How ab

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

ut a good book? Nah, not in the city of financial robots. Sometimes I think some people can't wait to keel over so the stress can finally be taken away. Of course, this has

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

major negative societal effects. Criminal "rappers" or "mobsters" become idols since they have the money. School becomes a "loser's way" in life. Quick, get-over schemes to

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

make money rule the day.

The American dream was always to go to school and get a job. Then, when enough money was saved-usually a moderate amount-buying a home would come n

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

Professional from academic institutions, pharmaceutical industries, health care indust

xt followed by a raising a family. In NYC along with some other places, that dream has died. To work a job making around $50,000 a year and for a house to cost around $500,0

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

0, something has to give. It usually is the person's mental health.

So, don't be surprised in the future when more and more studies compare NYC to a third-world nation-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

super rich and everyone else. How far this will advance politically is anyone's guess. America is very skilled at knocking off third-party contestants. However, this racket

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

Companies that provide selfless information through particip

annot continue forever. Money has become the "god" in too many places. Why would a reaction against this insanity be any different here as it has been in Brazil or Venezuela

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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