Advice Pool - Relationships

As the blinding flash of lightening and the rumbling roar of thunder, so it is with surprises and ideas. And especially with our o

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

wn “ah-ha!” moments.

Isn’t it fascinating how not one of us is absolutely perfect? We have threaded our way through life, doing t

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

Examples of combination products may in

e best we know how. Sure, we all have weaknesses that get the best of us at times, but for the most part, we really are doing the

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

est we know how. And yet, after all we have done, we still find that we fall short in the consistently perfect department. So we a

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

ain refocus our direction, reset our sights on the goals that we have set for ourselves, and step out on our own paths to success.

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

Combination pro

And we should be pursuing all the paths to success that we can possibly handle, because that is the way we also develop our comple

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

e potential.

The important thing is that we are willing to acknowledge our mistakes and make course corrections as needed. That i

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

s the best we can do. That is the most we can do. Nothing more can be expected of us as we continue threading our pathway through

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

ife.

And that is the most we can expect of our partner, too. To make a union work, on the long term, we need to be willing to for

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

ive and forget. Granted, that is not always an easy thing to do. Some things our partners do may sting and hurt us badly. But in t

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

e long run, the best thing to do is move onward.

We have the two choices: Stay or leave. Was the offense really bad enough to hav

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

Following aspects would a

to consider the two options? Is the damage done to our hearts really so deep and irrepairable that it can never go away?

Only yo

dd to the challenges in developing combination products:

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

can decide the answer to that. Was it really that bad, or are we just unwilling to forgive and forget? Ponder the true gravity of

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

the offense. Keep in mind, that to leave means total life changes, and they do not always turn out for the best. Sometimes, of cou

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

rse, they can, in the case of leaving a truly abusive situation. But is your partner sincere in their efforts to change? Do their

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

fruits” prove the pudding?

To forgive and forget means to let it go. We may be justified in being somewhat cautious in our action

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

Professional from academic institutions, pharmaceutical industries, health care indust

, allowing them ample time and space to prove themselves. But we also need to work on the “forgetting” part. That means, simply, t

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

at we do not continue to dredge up the past when it seems to support our “position”. We need to truly “let it go”.

Happiness is f

.

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

und in whatsoever places we look for it. The negative paths we follow from time to time will never turn up Joy. Joy and Happiness

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

Companies that provide selfless information through particip

an only be found on the pathways of forgiveness and forgetting and moving forward with our lives.

Try it out. It may surprise you

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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If you want employees to step up to the plate, it's up to you as their leader to empower them to take responsibility. They have to be comfortable confronting problems and coming up with potential solutions. You have the power to help them find the solutions, articulate the changes and develop the courage to point out what everyone else is thinking. If you want to turn complainers into problem solvers, there are four things you must never say to your employees.

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Advice Pool - Forgiveness and Forgetting

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