Advice Pool - Self Improvement

Yesterday was a great day. It was one of those ‘once in a while’ days when you feel totally connected with Heaven and Earth. I existed totally in the moment, and completely detached from all past and present stresses. I felt as if I were floating on a cloud. But that is not what made the day so special. No,

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

you see, yesterday I spent the entire day with my 4 ? year old son, and he showed me something that we all sometimes forget—that love, in it’s pure form, is the power of the universe, and that no matter what is happening in your life, love can make it all better.

The day started out as many do. I woke early a

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

Examples of combination products may in

d wrote for a while. I let our dog out and refreshed her food and water bowl. I straightened the living room and did last night’s dinner dishes. Everything was all so normal. I finally heard the bouncing up and down on the bed from the second floor of the house. I knew my little buddy was up, so I brought hi

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

m a drink of milk. We exchanged our mooring hellos and hugs. He asked if he could play in his room for a while, and I agreed.

The day was shaping up nicely. It was eight o’clock and not a cloud in the sky. It was about 65 degrees, and the heat of the sun was quickly warming the earth. It was going to be bea

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

tiful. I sat at my desk and connected to the internet, as I do most mornings. I checked to see if I had any email; I didn’t. I then went to view the morning’s news headlines. The Katrina aftermath and the price of gas topped the headlines, once again. Sadness swept over me, and I became a bit worried about

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

Combination pro

he state of our great country and all the people living with loss and sadness. So many struggles, so much loss, so much pain. I sat in quite contemplation for a while, until the silence was broken… “Can we go for a hike in the woods, Daddy?” my son asked with a huge smile on his face. “Sure, buddy,” I replied,

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

and after a good breakfast, I packed him and our Aussie into the truck and off we went.

Gazing at the gas prices, as I drove towards our hiking destination, I had a sinking feeling in my stomach. How could many Americans on fixed budgets deal with this rising cost. I started to worry about my ability to sus

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

ain my household. As the fear of the unknown crept into my mind’s thoughts, I slowed down—to conserve gas, of course. This is crazy I thought, and I thanked God for everything I had in my life. I remembered the long conversations I had with my good friend Mark, who went off to Seminary to become a Pastor. We t

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

lked about verses like (John 16:15) “All things that the Father hath are mine,” and (Matthew 6:33) “But seek ye first the kingdom of God, and his righteousness; and all these things shall be added unto you.” I also pondered the spiritual law of attraction, which says the universe will supply all the wants an

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

d needs in your life, if you just ask and believe…

But in these troubled times, seeking anything spiritual is sometimes a task, as we try to cope with the world’s massive losses of the past few years, form incidents like 9/11 the Tsunami and hurricane Katrina. Not to mention where do we find the extra wallet

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

ull of money to fill our gas tanks to get the kids to school and drive back and fourth to work.

The essence of the beautiful day escaped my grasp, as these thoughts clouded my head. Finally, we arrived at the trailhead. I love being in nature and so does my son. We hit the trail, with our Aussie leading the

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

Following aspects would a

way. I was silent and slightly detached as I thought about the state of the world, but my son, however, was quite the opposite. ‘Chatter Box’, is the best way to describe him. He was rambling on and on and on, about nothing really. Talking about frogs and salamanders, and the squirrels in the trees. He was

dd to the challenges in developing combination products:

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

asking me question after question about our woodsy surroundings. I started talking with him, answering all his questions, as we made our way to the summit.

My mood lightened a bit, as I enjoyed this time with my boy. I love being with him. He’s so eager and innocent and ready to explore the wonders of the w

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

rld. Wide-eyed and smiling all the time, I can’t help but be in a good mood when he is around. As we made our way up the steep section of this particular trail, he had some troubles. I let him figure out the path on his own, only briefly suggesting where he should put his feet and hands. As we came to the t

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

p of the small rock ledge, he said; “I think we are lost, Daddy,” Then excitedly exclaimed; “Look, a blue line on the tree. “This way, Daddy. This way—come on—come on!” I told him what a great hiker he is and thanked him for finding the way… Then it happened.

There was a brief silence as he walked towards th

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

e tree with the painted blue trail marker on it. I was happy, but still in the back of my mind was worry and unease. Then, at that moment, my 4-? year old son turned to me, out of the blue, and said; “I love you, Daddy!” He rushed to my side and gave me a huge hug and kissed my cheek. My heart suddenly melted

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

Professional from academic institutions, pharmaceutical industries, health care indust

and I started to cry. “I love you Daddy,” rang through my mind and suddenly the stresses of the world did not affect me any longer. I was elated, and felt as if I ascended instantly to the lands of Heaven. “I love you Daddy,” with those simple words, life, with all of its pitfalls, horrors, plights and dange

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

s was magnificent! Love really is the answer, for no matter what would of or could of happened to me at that moment, I was basking in the light of love, and everything was okay. John 4:12 says “No man hath seen God at any time. If we love one another, God dwelleth in us, and his love is perfected in us.” I,

.

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

at that moment, felt the perfection of God’s love within me. And it all seems so clear. Love God, love yourself, love one another, love the earth and everything will be okay…

So today I wake and give thanks for everything I have and the love, which is in my life. The headlines are still filled with sullen wor

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

Companies that provide selfless information through particip

s of Katrina and the death toll. Gas seems to have stabilized, for the moment, and the sun again warms my back yard. But today my outlook is different. Today I live with love, compassion and gratitude, and not stress and dissonance. What is the difference from yesterday? My Son’s gift of Love…

© Dave Ferruol

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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As I've been reading the trade magazines recently, I've paid particular attention to the channel magazines. A big story for several months has been the change in leadership at HP, since Mark Hurd took over as CEO from Carly Fiorina. This change has been met with much interest and concern for two reasons: 1) HP is a VERY BIG supplier to channel and 2) The company that Mark Hurd formerly led, NCR, utilized the channel to a far less extent than HP. So the natural concern is Hurd may steer HP toward a greater percentage of direct business in their distribution model.

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