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I do not believe that unethical behavior can unknowingly occur if a leader has proper values and intentions. A leader w

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

ho is ethically based will not knowingly break laws, deny rights, endanger lives or deceive or exploit employees, custom

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

Examples of combination products may in

rs, stake holders or society.

However, I do believe that an ethically based leader may find him or herself in situation

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

where they have discovered that they have acted inappropriately due to others in power who have deceived others in orde

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

to take advantage of the situation. For example, if a leader discovers funds have been misused, or expenses exaggerate

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

Combination pro

, or discrimination or other unethical behavior has occurred in a department or company, this becomes the moment of trut

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

for any ethical leader. At that moment, an ethically based leader will make a decision to fight to correct the problem

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

within the company, notify authorities or leave the company. This may seem simplistic, but I believe that if more lead

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

rs stood up against unethical behavior, there would be less of it.

In my opinion, the problem of corporate scandals rel

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

tes to a general decline of ethical standards within society as a whole. An employee who cheats on an expense account,

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

r takes supplies from the supply room, is as guilty of stealing as the corporate executive who cheats employees, custom

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

Following aspects would a

rs or stockholders. While, one may be more costly, and has greater negative impact than the other, they are both ethica

dd to the challenges in developing combination products:

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

ly incorrect. For this reason, more time and energy needs to be spent teaching general ethics to employees and executiv

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

s. With communication and training, it is clear to all involved what is ethical, and how to address problems when they

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

are discovered.

I believe that a true leader must not only drive results for a company, but must also realize their soc

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

al contract they have with employees, customers, the community, etc… When profits, career advancement, and greed are no

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

Professional from academic institutions, pharmaceutical industries, health care indust

balanced with a social conscious, then grey areas between right and wrong become more difficult to distinguish. When m

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

suse of funds, or misappropriate use of employees, discrimination, etc., occur all of us have a choice. We can ignore i

.

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

, and become accomplices to the problem. We can fight to improve the situation in order to be leaders in improving the

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

Companies that provide selfless information through particip

ituation. Or, if we cannot improve the situation internally, we can leave to find a better ethical match somewhere else

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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