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Daily I am visited by the angry. Their expressions of rage are cries fo

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

r help; however these are not innocent cries. As angry cries ring out,

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

Examples of combination products may in

a trail of emotional and physical destruction litter their path. Someho

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

society tend to ignore the small droplets of destruction until inciden

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

ces like the Virginia Tech massacre and the killing at NASA remind us

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

Combination pro

of the horrendous price that anger can exact.

I mourn the lost of life

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

in these senseless tragedy. As I struggle to understand this devastatio

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

n, I have so many questions. How did this happen? Could it have been pr

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

evented? What role if any did anger and trauma play in this incident? W

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

at interventions may have possible helped? How can the anger management

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

community be of more assistance to stem the growing problem of anger?

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

Following aspects would a

I now turn to my anger management colleagues across the country. We mu

dd to the challenges in developing combination products:

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

t do more. We must become more visible (write more, speak more). Improv

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

e your training in stress management, emotional intelligence, and commu

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

nication skills. Increase your knowledge of the connection between trau

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

a and aggression. My ultimate desire is that professionals specifically

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

Professional from academic institutions, pharmaceutical industries, health care indust

trained in anger management become a force for change in the way destr

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

uctive anger is identified and treated. We must assist society in findi

.

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

g viable ways to treating the angry. This is our obligation. In the mid

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

Companies that provide selfless information through particip

st of this painful tragedy, it is clear that we CANNOT ignore the angry

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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