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Main Subject - Quick Tip - Shushing a Loud Cell Phone Talker
Janet, one of my clients from Chicago, recently asked my advice on dealing with people
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
who talk loudly on their cell phones while in public. I know I’ve been guilty of thi
; 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
offense before as my voice tends to project very well and sometimes I forget that I d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
on’t need to speak very loudly for my phone to pick it up.
Sometimes, like when you’r
Sometimes, like when you’r
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
in a movie theater, any kind of loud cell phone talking needs to be quieted immediate
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ly and the most direct way is the best. But often in public, you may feel a bit awkwa
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
d telling a stranger to mute him or herself.
The other day at the gym, I found myself
The other day at the gym, I found myself
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
in this second scenario. I was on a treadmill with my headphones on. Despite the no
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
se of the machine and my music, I could easily make out the cell phone conversation of
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
a woman who was on nearby treadmill. She wasn’t directly next to me so she wouldn’t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ave heard a, “shush,” sent in her direction. I decided to try to use a different appr
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
ach to the situation.
After I finished my workout, I walked over to the woman, who by
After I finished my workout, I walked over to the woman, who by
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
then had ended her call. I leaned in and whispered, “We have something in common.”
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
he looked at me a bit puzzled and I added, “We both tend to talk a bit loudly on our c
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
ell phones. It’s always getting me in trouble.”
The lady then nodded with understand
The lady then nodded with understand
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
ng. “Thanks for the tip,” she said.
Who knows whether my cell phone intervention wil
Who knows whether my cell phone intervention wil
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
l result in any permanent change for the women but I have noticed during subsequent vi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
its to the gym, that she speaks a lot softer on the phone.
Sometimes a blunt approach
Sometimes a blunt approach
.
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
to a problem is best. But other times, a more gentle touch may work better. By crea
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
ing a situation where I admitted a shortcoming, I made it easier for someone to change
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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