Main Subject - Business

I recently called for technical support from my ISP, (because I could not connect about my issue any other way I tr

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

ied,) to check with them about an issue I wanted to confirm my own suspicions about.

After spending a half hour on

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

Examples of combination products may in

the phone with the foreign gentleman, I decided to end the conversation because we were not connecting well. Follow

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

ing the call, I received an email from the "engineer" who attempted to answer my question. Here are actual excerpts

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

from that message: “hi John, i am mailing this link for u to get ur problem of bouncing back emails be fixed pls

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

Combination pro

make sure that u down load the software and run it on ur computer, the link is (excluded) with regards Sam tech

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

ical voice support”

Now, in my own background, I provided complex support at an engineering level for a number of

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

companies, and though I could not always give customers the answers they wanted to hear, I did use reasonable Engl

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

sh in my vocal and written correspondences. In this particular case, the advice I received did not even come close

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

to identifying the real problem, much less an adequate solution. Communications like the one above have become th

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

norm for today's quality of support, because they took it away from us to save the company money and please the sh

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

Following aspects would a

reholders. Proportionately, the shareholders of such companies receive a far smaller cut of the improved profits t

dd to the challenges in developing combination products:

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

han the executives that choose to do business this way.

One thing I am certain about; I would have been fired the

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

ame day I produced a customer response like the one shown above. If we need to go to a far away land to find this q

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

uality of communication, perhaps we could obtain the equivalent of an HB-1 visa in that country to have the opportu

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

ity to train them how to speak and write in English. If American customers are not worthy of receiving adequate En

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

Professional from academic institutions, pharmaceutical industries, health care indust

glish speaking support in their own country, what does this tell us about the value of our consumer dollars and our

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

work ethics?

Seeking to do business with an uneven playing field will result in the ultimate degradation of the pr

.

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

iority objective for preserving the prosperity and focus on the people we serve in this country. For American busi

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

Companies that provide selfless information through particip

esses, raising the standard of living for foreign interests should not be a higher priority than preserving our own

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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Many corporate managers have been introduced to a corporate management system called the Balanced Scorecard. Developed at the Harvard Business School by David Norton and Robert Kaplan in the early 1990s, the Balanced Scorecard (BSC) represents the newest and most prolific performance measurement system since Total Quality Management (TQM) and Management by Objectives (MBO).

Employers are constantly searching for people who have the drive to work hard and the integrity to do the job well. Are you that kind of person?

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