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E-Articles - Know your Man: Changing Rules
“The more things change the more they remain… insane.” ~ Michael Fry & T. Lewis
“Majority rule only works if you're also considering individua
“Majority rule only works if you're also considering individua
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
l rights. Because you can't have five wolves and one sheep voting on what to have for supper." ~ Larry Flynt
First we want this… Then we chang
First we want this… Then we chang
; 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
our minds and want that… Then we revert to our first position. How are men ever supposed to know what to do?
There is no escape; it is part o
There is no escape; it is part o
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
f our nature: We change the rules just as we please and life becomes very uncertain for our men, for suddenly what was ok last week is not anym
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
re and then we argue when they don’t follow the rules. Let’s be consistent about what absolutely needs enforcement and what we can let go of. A
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d when it is imperative to change rules, let’s make sure they agree with them.
My friend Danny and his wife used to invite several of us, frie
My friend Danny and his wife used to invite several of us, frie
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
nds, for Sunday brunch. It was always a cause for celebration. After we ate, we would help clear the table and all of us would come right back
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
o we would continue visiting. The time we spent around the table was fantastic. Cleaning the kitchen and washing the dishes was an activity don
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
much later in the day, after we all had had our share of visiting. The pace was slow and we loved the relaxation, until one day, while we were
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
at the table, laughing our hearts out, we noticed she was not sitting with us. She was doing the dishes! My friend went to speak to her and we
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
could hear this big argument because he had failed to help her do the dishes. Now, talk about changing the rules during the game!
I think situ
I think situ
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
tions like these are very humiliating for everyone, guests and husband, especially the husband. If she wanted the “clean the dishes” rule chang
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
ed, she should have followed it herself, instead of having a tantrum in front of the guests, or even better; she could have waited until we lef
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
to have a conversation with her husband and give the new rationale for the change of heart and then they would decide in unison what to do abo
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
t the situation.
Now, looking at the other side of the same coin, another couple friend invited us for dinner the other night. After we ate, h
Now, looking at the other side of the same coin, another couple friend invited us for dinner the other night. After we ate, 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
e cleared the table and disappeared into the kitchen to do the dishes. When he came back, it was already time for us to go. That means that he
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
issed the whole after dinner conversation. When I asked him why he did that (for it was only when I noticed this habit of his), he told me that
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
this is one of his chores and he has been doing it for the longest time. He’d rather take care of the dishes immediately to avoid nagging later
.
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
on. Now, could this rule be changed so everyone can enjoy visiting?
A Word of Advice:
Ladies: Please, think a lot before changing a rule tha
A Word of Advice:
Ladies: Please, think a lot before changing a rule tha
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
has been enforced until now.
Gents: Never accept a new rule until it is discussed and agreed upon by both parties. Plus, tantrums are a no-no
Gents: Never accept a new rule until it is discussed and agreed upon by both parties. Plus, tantrums are a no-no
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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