Advice You - Business

Are you surprised when you read and hear about all of the corruption within business these days? I'm not. The way people act

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

in business situations is nothing more than a reflection of how they act in their normal lives. Why would we expect anything d

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

Examples of combination products may in

fferent?

I am a follower of rules. I believe that rules are there to give everyone an equal opportunity to enjoy the benefits

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

that our great nation provides. I get angry when people don't follow the rules.

I don't like seeing people park in handicap

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

ones, with or without a handicap tag, when they don't need to. I get irritated when shoppers take 15 items and check out in a

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

Combination pro

10 item or less line. I don't like to listen while people talk about how they managed to by-pass the cable company and get the

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

r cable TV for free. You get the idea. When people don't follow the rules, those of us who do pay the price. I guess those f

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

olks believe that the rules are made for everyone else and not for them. Their selfishness comes before rules.

I have a sign

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

n my wall that reminds me of this, it says, "He who follows the rules gets screwed." It is not there to suggest that I not fol

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

low rules, rather to remind me not to get too angry when people don't. Every now and then I get comforted when I see someone w

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

o did not follow the rules get their just reward.

Last week a news story reported that an elementary school teacher was arrest

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

Following aspects would a

ed in her classroom in front of her class. The story, and of course, the lady arrested, thought it was horrible that the polic

dd to the challenges in developing combination products:

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

came into the school room in front of these young children and embarrassed her over a parking ticket that she did not pay. It

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

turns out she had more than one outstanding parking ticket and they were several years old.

To bad lady, you broke the rules

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

nd thought you could get away with it. The fact that you were embarrass in front of your class is your own fault. Do you thin

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

k those of us who follow the rules should be considerate of your feelings when you obviously don't care about ours? And the ki

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, let them see what happens when people don't follow rules. Let us reinforce good actions by clearly punishing poor actions.

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

My hope is that by doing so, these kids will grow up following rules. Remember, the way people act in their normal lives wil

.

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

carry over to their business lives. Do you want businesses to become less corrupt? Cheer the small victories we get when tho

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

Companies that provide selfless information through particip

se who refuse to follow rules get caught. I want to change my sign to read, "He who follows the rules wins."

To Your Success

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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