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5 Year Anniversary of 9/11

Where were you 5 years ago on September 11th? How has your world changed since that day, when New York City, Washington DC, and Pennsylvania were scarred by planes crashing, when daily life was disrupted by groups of people from far away cultures wi

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

th anger toward the United States?

The news media in the United States, and I suspect from around the globe, will be “hyping” this anniversary to improve their ratings and to maintain their controlling position over public anxiety and irrational hysteria. September 11, 2001 has chan

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

Examples of combination products may in

ged our world in many ways. We all must adapt ourselves to new parameters when traveling, communicating, doing business, interacting with various cultures, and psychologically, if not physically, protecting our families.

The world has become a smaller and, perhaps, a more insecure p

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

lace. We can not afford to be so na?ve or so locally focused. People from very remote parts of the world are trying to get our attention and their desperation for attention has taken some very rude directions. As we take our heads “out of the sand,” we are looking at situations that

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

we can not control and might have life or death implications for people we care about. This is the definition of negative stress. When we care about someone or something, but can not control what happens, then we are often in a position of being victims to the perceived stress from t

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

Combination pro

hese uncontrolled situations.

We can not control how other people feel or how they might react. The only thing that we can control is the way we respond in these difficult situations. Now, more ever before in human history, we must learn to control our reactions and, in so doing, co

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

ntrol our health and our available energies.

Time management and setting priorities is important. Understanding our unique basic needs (requirements) and finding ways of meeting these needs becomes more important. Learning how to eat “right” and exercise “right” and the practice rel

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

axation/stress management are all more essential. Being positive role models for our children, our spouses, our friends, and even our co-workers is more important now.

All of these counter measures begin with venting our fears and frustrations. After we can get these out of the dark

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

corners of our minds, then we have the opportunity to have perspective and to practice the self-care techniques that can keep use from becoming “victims” to our own fears and stresses.

If you feel like participating in a venting process and then a search for positive solutions to o

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

ur September 11th anxieties, then join us on the 5th anniversary for our conference call to share our stories and search for useful positive solutions to our personal stress and anxiety.

My 9/11 Story: Like everyone else, I experienced a very unique and life changing reacti

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

n to the events of 9/11 in 2001. Everyone had their own history of events and life situations in place when we had our world shaken by the unexpected and completely unusual events of that day.

For me, the trauma actually started before September 11, 2001. My mother had had a stroke

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

Following aspects would a

(CVA) the week before 9/11 and she passed away the evening of September 10th. I was emotionally involved in grief and coping with the tragedy. A family friend called me early in the morning of September 11th to ask if I was watching television and aware of the events unfolding in New

dd to the challenges in developing combination products:

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

York City. I rushed to the TV and soon was caught up in the drama of watching “live coverage” of events that I did not understand or had ever imagined. When people are scared or anxious they crave more information in an attempt to figure what is going, how to survive, and what possi

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

ble actions should they be taking to keep from dying (or having loved ones die.) After 30 minutes of media chaos, the telephone rang again. It was the local television news broadcast asking if I could down to the TV station and go “on-air” to provide “stress management” to an anxious

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

local world of viewers. I could not say “No,” nor could I figure what exactly I could do or say to be helpful. Somehow, I got down to the TV station in about 30 more minutes. As I drove myself, my mind was filled with my personal grief, confusion, anger, anxiety, and lack of certain

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

ty as to what all this would mean. I looked into the faces of people driving their cars and saw wide-eyes and upset and confused faces. At the TV station, they put me on camera and asked me to solve their viewers’ anxiety. Stress management in a state of crisis is not the highest pri

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

Professional from academic institutions, pharmaceutical industries, health care indust

ority for most people. Survival is. But I did manage to say an important thing regarding viewer’s anxiety. I said, “If you find that you are too overwhelmed by anxiety and media created confusion, you should consider turning off your TV and getting support from your family and friend

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

s.” People are desperate for information during a crisis, but being bludgeoned by repeatedly seeing planes flying into buildings, did not seem particularly useful to me as a professional “advice giver.”

Two weeks later, I had to fly out of state for a seminar that I was leading in P

.

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

hoenix, AZ. It was a very weird experience. Travel was different. Security was different. Lack of security was a huge issue. The behaviors of uncomfortable co-travelers was judged and felt suspicious. It was weird. Traveling is not the same. There is more fear and insecurity than bef

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

Companies that provide selfless information through particip

ore 9/11. We all have to adapt. We all have to learn how to cope. And, in this changed world, we all have to learn how to take even better care of yourselves and our children so we can have the highest quality of life in a damaged world…

Please take good care of yourself.

John Maso

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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