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Top Articles - A Stolen Identity: Cautionary Story
A friend recounted this true story:
The phone rang one day. The voice at the other en
The phone rang one day. The voice at the other en
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
d sounded unfamiliar but official. “Is that Mrs Malone?”
“Yes”
“This is Detective In
“Yes”
“This is Detective In
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
spector Morgan of the Metropolitan CID”
“Oh?”
“We would like to travel up to see you
“Oh?”
“We would like to travel up to see you
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to ask you some questions”
“Oh … OK”
A few days later and my friend was sitting in
“Oh … OK”
A few days later and my friend was sitting in
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the police station confronted by two officious looking, but thankfully pleasant, Detec
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tive Inspectors.
Then came the questions. What was her full name, address, telephone
Then came the questions. What was her full name, address, telephone
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
number and occupation ? Where did she work and where did she live? In fact where had
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
she ever lived? Did she own a mobile phone and when was the contract taken out? Who do
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
es she live with and hang around with and what were her movements on a specific date m
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
entioned by the officers?
The questions continued and, although she didn’t feel at al
The questions continued and, although she didn’t feel at al
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
l threatened, she was bemused and increasingly suspicious.
Then came the bombshell. S
Then came the bombshell. S
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
omeone had stolen her identity and taken out a mobile phone in her name. A credit hist
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ory had been initiated in her name but for someone else’s benefit.
It got worse.
She
It got worse.
She
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
was shown a photo of a rough looking man. Did she know him? Had she ever met him? Cou
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ld she be sure?
It turned out that the man was wanted for rape. The connection with h
It turned out that the man was wanted for rape. The connection with h
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
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
im and my friend was that his girlfriend was the one that had stolen her identity. She
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
was also wanted for criminal activity.
So now, my friend had a stolen identity, a cr
So now, my friend had a stolen identity, a cr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
edit contract taken out in her name and there was a criminal connection between “her”
.
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
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
identity and a suspected rapist.
It was all sorted out and my friend’s name was withd
It was all sorted out and my friend’s name was withd
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
rawn from police inquiries. The matter was, however, deeply unsettling and unpleasant.
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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