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When my wife, Bobbie, died, I never anticipated what the repercussions might be when I purchased a double- header. Excuse my mortuary lingo. A double-header is a double headstone where two people, usually married, have their names engraved on their burial tombstone at the cemetery. Sometimes an inscription reads “together again.”

I brief

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

ly worked for a mortuary many years ago. It was then, my family decided to pre-arrange their own funeral and burial arrangements. When my parents did their arrangements, my aunt and uncle followed with theirs. I liked the idea and thought it was a smart idea. Then it came my turn many years later, when my wife passed away. I never thought it

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

Examples of combination products may in

would bite me in the mouth if I decided to date or marry again.

It was two years since my wife had died, that I thought I was ready to start a relationship again. A kind gesture on my part, instantly angered my new girlfriend. We were sitting outside on my deck, when my girlfriend said she was cold. So I went inside to retrieve two jacke

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

s. I was cold, also. When she saw my jacket on, while I was about to put hers on, she asked, “why do you have two jackets the same?” I sheepishly replied, “it was my wife’s.” She was angered by my comment and was taking off the jacket I put on her, and she dropped it on the deck and she told me, “I’m not your dead wife!” Her comment hurt my

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

feelings. I was careful not to bring up my wife or anything that related to our marriage because I knew that wasn’t the way to go in a new relationship. I made an innocent gesture to comfort her while she was cold and it turned into a nightmare. I tried to explain but it fell on deaf ears. I was angry myself, so I let her go stew on it.

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

Combination pro

he left in her car.

I kept thinking about that situation, and I pondered over in my mind whether to apologize. I did that, but on the other hand I thought to myself, “what a snob she is.” Sometime later, another blooper came out and settled just outside my big mouth. I had told my girlfriend, after we made up, that I had a double headstone

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

on my grave. She was angered once again by my comments. My comments were made while I further explained to her about my two identical jackets.

After my remarks were forgiven, I decided I wasn’t going to ask her to move in with me, until my new house next door was built and finished. I wasn’t going to have her move in to a place I shared with

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

my wife. I knew something would come up and she would pitch a fit. Then it came time for me to ask her to move in and she said she would—a big mistake.

It wasn’t long after she moved in, that I thought I better move this circle-planter I had made for my wife when the new house was only a vacant lot. The circle-planter I made for my wife w

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

s obstructing the new driveway, so it had to be moved. The planter consisted of a concrete-painted bear I gave to my wife for her birthday. I later bought a miniature windmill and placed it by the bear. Then we planted roses around this landscaped circle. Next to it, there sat a big rock. I painted the rock blue for the sky and drew in white

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

for Mt. Rainier in

the forefront. Then I emblazed the words, Bobbie’s Mountain, in black lettering. My wife loved it. We named our property Bobbie’s Mountain because our house was on a hill like a mountain, and we had a gorgeous view of Mt. Rainier from our front yard. We loved Mt. Rainier. It was our fa

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

orite place to visit.

When it came time to move the planter or dismantle it, I called a friend to help me move the heavy concrete bear and relocate it over to the other place next door where I lived with my wife. I was going to keep that property and rent it out some day. As I was setting it up over there, I had displayed the arrangement th

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

Following aspects would a

e same as it was, except it wasn’t in a circle anymore but in a large area I landscaped to fit it in. Now the arrangement was set, and I had it facing the new property. The rock still read Bobbie’s Mountain. I thought it looked great in its new location. This way I could view it from my new house--a big mistake.

Before my girlfrien

dd to the challenges in developing combination products:

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

d could see it, I covered the rock that read Bobbies Mountain with some landscape fabric. I knew some day, in case this new relationship didn’t work out, I could just take off the fabric without redoing all my artwork. I thought the idea was a smart move on my part.

As months passed, it turned out that my girlfriend really wasn’t meant

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

or me. We parted our ways-- and not in good terms either. I just thought how insensitive she was to my precious memories of my past. They meant so much to me and I thought I was being careful not to mention my past. It just didn’t please her what ever I did to keep mum.

When she moved out, I held my own celebration. Not only did I unveil the

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

rock next door, I moved everything over to the new property and constructed a new site. Now it has a thirty foot flag pole with the bear next to it. The old windmill made of wood had broken down from rot decay, so I discarded it. The heavy rock with the art on it was too heavy to move, so I left it behind and I painted over the artwork in

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

solid grey. Now I have the most gorgeous memorial garden a person could imagine. Instead of the infamous rock, I placed a granite marker next to the bear and flagpole that reads: “In loving memory of my wife, Bobbie Jean, my yellow rose of Texas, who affectionately named this land, Bobbie’s Mountain. And to my aunt and uncle, E

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

Professional from academic institutions, pharmaceutical industries, health care indust

dith and Vernon Thomson, who made my dream home come true. And to my parents, Amanda and Hank Erickson, who gave me life and love.”

I wanted to include my aunt and uncle, who passed away and left me a huge inheritance to build my new dream home and to my parents who gave me life and love. Now I have the best of both worlds, with the

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

new memorial addition-- in honor of my wife, my parents and my aunt and uncle.

As far as future relationships go, I will move slow and careful from now on. If jealousy and anger move my next girlfriend into a tizzy, I will never claim her as my girlfriend or my wife. If a double header and casual memories of a life before upset

.

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

a new relationship, she can look for love elsewhere. I do not see anything wrong with honoring my wife’s memory. And I don’t see anything wrong with having a double header at my cemetery. After all, when I married it was meant to be forever.

My advice for people in my predicament? Think twice about purchasing a double header, because w

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

Companies that provide selfless information through particip

here else will your second wife be buried? Obviously not with you. Maybe next to you--in a single headstone? And as for digging up bones--excuse the pun--recalling past memories, be well aware of the consequences. And if you end up with somebody that is insensitive to your needs, like I did, do what you think is right--you won’t regret it

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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