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It was 1967 and I was overseas in a recon outfit. It had been many months since I had experienced any contact with a love interest from the good old USA. I had gone to mail call almost daily and received nothing

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

but an occasional letter from my folks. Most of the guys who had come over with a love interest had lost out due to the infamous dear John letters. I was content to pass my time and wait to be released from the

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

Examples of combination products may in

rmy and return home to a life that had been interrupted due to a draft call to the service of my country. At that time in American history there was considerable resentment to the war and to the armed services in

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

eneral. During an emergency trip home because of severe problems I had been subjected to heckling while traveling through air ports. Wearing a military uniform in public in the United States was not a strategy on

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

would use to become popular among the masses. I was not brought up in a military background and was not thrilled with the idea of someone shooting at me and laying on a piece of ground with most of my body parts

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

Combination pro

issing. I had been raised by responsible parents to act accordingly. I entered the military determined to fulfill that responsibility.

I went to mail call in my customary fashion expecting to be ignored. I was

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

ewarded with a letter from a girl that knew my name and knew some things about me. I had never met this woman and her identity had escaped me. She began a writing campaign that would be the envy of anyone. She bom

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

arded me with letters daily and I responded in kind. I was informed that she was an acquaintance of my sister. I had never met her but meant to look her up when I returned to the States.

Returning home after all

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

those years was a glorious occasion. I was glad to see my folks and family again. The mystery woman appeared at my parent's door step one day. I had been injured over seas and was wearing a cast on my arm from s

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

oulder to wrist. She offered to drive me around town since I was unable to do so myself. We spent more time together and eventually married. C.G had come from a family of divorce. She was living with her single

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

parent when I was introduced to her. We moved into an apartment. After the cast was removed I enjoyed employment while taking classes at the local college. I had never thought about having children with her but

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

Following aspects would a

hen she told me that she wanted children we were rewarded her with her first pregnancy. During that era women were burning their bras and demanding autonomy and independence.

C.G. left me one day and went to her

dd to the challenges in developing combination products:

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

other's house. She never reconciled with me and we eventually divorced. K.M. was born out of that union. I continually tried to make contact after C.G. moved to another city with my child. C.G. moved from place

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

to place and I eventually lost contact with her. I later learned that she had put an ad in the paper and when I did not immediately answer it she had my child adopted by another person. All the inquiries and comm

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

nication between K.M. and I had come to a brutal halt. Right before her graduation from high school I found Kriste and tried to rekindle communication. I found out later that C.G. had told my daughter that I was

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 drunk and a wife beater. None of that was true. She told me that her mother did not want her to talk to me anymore. I honored her wishes.

Just six months ago I received information that K.M. was seeking me ou

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

Professional from academic institutions, pharmaceutical industries, health care indust

and wanted to talk with me. I responded and called the number that I was given. I was told that none of my communication had ever reached her. The gifts and letters that I sent to her were never received. Her

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

other had told her much information about me that was inaccurate and untrue. Since that time Kriste has accused me of leaving her. That is not true. The years of verbal bashing by her mother has taken its toll. S

.

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

e has looked for the smallest detail in my character that would justify the years of untruth that her mother has told her about me. K.M. has my phone number and e-mail address. The phone does not ring and communi

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

Companies that provide selfless information through particip

ation has stopped. I wait for her call but I do not expect much. Though I am desirous of resuming communication with K.M. I am conditioned to disappointment. I have heard that time heals all wounds. I am waiting

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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Just manufacturing a product or providing a service is not enough for any business. To be in the industry for a long run, it is equally essential to know how the products are being used by the end users, are they satisfied, what kind of changes do they look for etc.

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