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For companies to be competitive, decisions have to be made faster than ever before, and expenses

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

have to be lower. The hierarchical environment did not support fast decision making. Decisions fl

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

Examples of combination products may in

owed through a chain of command. If a decision was beyond your authority, you would have to refer

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

it to your supervisor, who would then refer it to their manager, who would then refer it to ...

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

and so on. The point is that decisions took too long. Further, considering the time required by t

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

Combination pro

e people involved in the process, it was also very costly.

In a team based environment, the boun

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

daries for making decisions and the necessary authority have been expanded tremendously. Now, in

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

many environments, the person doing the job makes the decision. This change in the decision makin

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

g process has resulted in faster, less costly decisions which, in turn, helps keeps a product or

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

service priced competitively.

"Individual commitment to a group effort - that is what makes a te

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

m work, a company work, a society work, a civilization work." Vince Lombardi

A team based enviro

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

Following aspects would a

nment demands that you make responsible decisions; it requires you to take charge of your career.

dd to the challenges in developing combination products:

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

It requires you to develop excellent interpersonal skills because you have to interact at a much

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

different level with your team members. No longer is it just you and your job!

"Alone we can do

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

so little; together we can do so much." Helen Keller

When you stop and think about a team bas

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 environment, it is perhaps the best structure we could ask for. Why do I say this? Because, we

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

Professional from academic institutions, pharmaceutical industries, health care indust

are adults who are quite capable of making decisions. In our personal life, for example, we do no

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

t have a manager to run to and ask permission. We are accountable for our decisions in our person

.

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

al life so why shouldn't we be just as accountable in our work life.

"Coming together is a begin

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

Companies that provide selfless information through particip

ning,
staying together is progress,
and working together is success."
Henry For

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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