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Anger is neither good nor bad! It is simply energy.

It is your natural emotional energy

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

that arises when you feel like something (or someone) is blocking you from getting what y

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

Examples of combination products may in

u need or want. For this purpose, anything on the frustration to rage continuum is consid

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

red anger.

Without making any judgments about whether you should need or want any partic

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

ular thing, here is how you can direct your own supercharged energy.

1. Notice that you

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

Combination pro

re angry. Sometimes it is unmistakable -- if you didn't restrain yourself you would be ye

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

ling or getting physical -- and getting yourself into trouble. Sometimes it is more subtl

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

e: a clenched jaw that almost feels normal, an ache in your gut, tight shoulders, or just

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

snapping at people who haven't done anything wrong.

2. Figure out why you are angry. Ag

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

in, sometimes it is obvious, and sometimes it is hidden in a jumble of normal activities.

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

Perhaps many small frustrations have added up to one massive headache.

3. Think about

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

Following aspects would a

what would need to change for your angry feelings to dissolve completely and be replaced

dd to the challenges in developing combination products:

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

ith satisfaction. Sometimes it is a simple as an apology. Sometimes nothing short of a ma

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

sive change in your environment will do the trick.

4. Use your energy to strategize how

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

you can arrange to make the change happen. If the necessary change is too big to manage

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

ll at once, think about a small piece of the bigger change where you can make an impact n

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

Professional from academic institutions, pharmaceutical industries, health care indust

w.

5. Take the first step. Maybe it is working on a physical task for 15 minutes to beg

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

in to clean up a mess. Maybe it is asking someone to do something differently! It doesn't

.

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

matter how big or small that first step is-do something now!

Your focused angry energy i

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

Companies that provide selfless information through particip

powerful. Keep using it to push for the changes that will make a real difference for 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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