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Encyclopaedia - Wrong Can Be Expensive
Often times, when we are confronted with a challenge, we look to those in our circle of influence for advice or direction. Maybe we aren't looking for advice, but simply venting to a friend, relative, or acquaintance. Sometimes, what follows a good vent, is unsolic
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
ited advice.
Some of us, like me, have a natural tendency to want to solve a problem or attempt to fix things. Some things I am well qualified to give input on and other things, well, not so much. In fact, I had a plumber at my house today as result of my tendency
Some of us, like me, have a natural tendency to want to solve a problem or attempt to fix things. Some things I am well qualified to give input on and other things, well, not so much. In fact, I had a plumber at my house today as result of my tendency
; 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
to want to fix things. Ahem...
What happens when we have a challenge in an area of our lives that we have no experience with or, the experience we thought we had led us to the challenge in the first place? Hopefully, we recognize a shortcoming, look for answers, a
What happens when we have a challenge in an area of our lives that we have no experience with or, the experience we thought we had led us to the challenge in the first place? Hopefully, we recognize a shortcoming, look for answers, a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d seek out our options. If we are talking openly about this challenge within our circle of influence, there is bound to be feedback, sympathy, and helpful suggestions.Some of these suggestions can come from the best of sources, ones with knowledge and experience th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t can be applied to the issue at hand. Our circle of influence, to my thinking, should be a resource that we draw upon.
But, sometimes, by following unqualified and inexperienced, though probably well intentioned suggestions, things can go very wrong. And wrong ca
But, sometimes, by following unqualified and inexperienced, though probably well intentioned suggestions, things can go very wrong. And wrong ca
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
get expensive.
I am writing this piece with a specific example of bad advice in mind that was given to a man that caused him a 5 figure financial harm that could have been avoided.
In April 2005, a man was referred to me that had run into some financial difficul
I am writing this piece with a specific example of bad advice in mind that was given to a man that caused him a 5 figure financial harm that could have been avoided.
In April 2005, a man was referred to me that had run into some financial difficul
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
y. At that time, an attorney in his local area had been contacting him about an unpaid credit card bill. The balance at the time was roughly $35,000.00. I explained to this man that, in my experience, it was very likely, due to the size of the debt, his assets, and
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
who the local law firm was, that their next step would be to file a law suit in order to collect. Based on his finances, his goals, and a strong desire to stay out of court, I assisted him in negotiating the account to a lower balance.
In the mean time, he struck
In the mean time, he struck
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
up conversation with a friend who encouraged him to join an organization that sells information that would completely eliminate that debt. He did talk to me about this program and, while I did not know that much about it by name, I knew plenty about other programs
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
hat sell a promise to zero out debt based on what I like to call "legal esoterica". It's where they claim to eliminate your debt if you buy their system that is based on several very secret legal procedures that most lawyers and even judges don't know about and whe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
applied correctly......POOOOF!!!!......DEBT BE GONE!!!!.......
I could not discourage him from moving forward in that direction. I did encourage him to ask certain questions and demand legitimate proof that said "esoterica" worked. I did not hear back from him. U
I could not discourage him from moving forward in that direction. I did encourage him to ask certain questions and demand legitimate proof that said "esoterica" worked. I did not hear back from him. U
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
til last week.
The promoters of this and other programs do a pretty good job of convincing people what they do really works. So much so, this man applied their process to two other accounts, as well. And...got sued. Not once, but three times. The cost for the priv
The promoters of this and other programs do a pretty good job of convincing people what they do really works. So much so, this man applied their process to two other accounts, as well. And...got sued. Not once, but three times. The cost for the priv
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
lege of this experience was roughly $2,500.00 paid to the promoters of "DEBT BE GONE".
Somewhere, in the course of being sued three times, he and his helpful friend figured out that the "POOOOF" program was not working as advertised. Luckily, someone came along an
Somewhere, in the course of being sued three times, he and his helpful friend figured out that the "POOOOF" program was not working as advertised. Luckily, someone came along an
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
must have said something like "Dude, no wonder you're in trouble, that POOOOF stuff is not utilizing the "legal esoterica" correctly. I have some powerful "legal dust" that will do the trick". And, for the additional cost of another $2,500.00 paid to the promoter
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
of "legal dust unlimited", the hallucinations continued.
When the "dust" settled, he was left with three judgements totaling over $110,000.00, liens upon his home, a brand-spanking-new wage garnishment, and a healthy amount of skepticism towards things that sound
When the "dust" settled, he was left with three judgements totaling over $110,000.00, liens upon his home, a brand-spanking-new wage garnishment, and a healthy amount of skepticism towards things that sound
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
oo good to be true.
It appears the courts, attorneys, and creditors were not in possession of the required decoder ring to make sense of the "legal esoterica" mumbo-jumbo. Nor were they willing to participate in the hallucinations provided by "legal dust unlimited
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
.
The judgements are roughly $20,000.00 in excess of what he originally owed and accruing interest, plus the $5,000.00 price for an education in what not to do. Wrong, in this instance. Cost? 25 thousand dollars.
Well meant or best of intentioned feedback can le
The judgements are roughly $20,000.00 in excess of what he originally owed and accruing interest, plus the $5,000.00 price for an education in what not to do. Wrong, in this instance. Cost? 25 thousand dollars.
Well meant or best of intentioned feedback can le
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d to problems and unneeded complications. If we are having difficulty in a specific area of our lives, we should look for qualified and successful solutions.
Obvious examples of this are:
Mechanical problems are best discussed with a mechanic, not an interior des
Obvious examples of this are:
Mechanical problems are best discussed with a mechanic, not an interior des
.
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
gner.
Marital issues can be discussed with a marriage counselor or a successful married person, not Aunt Mildred with 5 divorces under her belt.
Plumbing problems might be best handled by a plumber, not me.
The advice we seek or that is offered up can so
Marital issues can be discussed with a marriage counselor or a successful married person, not Aunt Mildred with 5 divorces under her belt.
Plumbing problems might be best handled by a plumber, not me.
The advice we seek or that is offered up can so
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
etimes do more harm than good. Consider the source and even the bias of the advice you hear. Get competent experienced second and third opinions.Would you take your financial challenges to someone with an ongoing inability to navigate their own financial challenges
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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