Tags |
|
|
Links |
|
|
Just Other Articles - A Hard Lesson Learned....
Are you like me? I like to handle things on my own so I don't even THINK about incorporating help with anything I am working on ..
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
. especially my business as a whole.
Well, I learned something new recently. It was a HORRIBLE experience that actually turned ou
Well, I learned something new recently. It was a HORRIBLE experience that actually turned ou
; 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
for the better. Let me tell you my story:
I have a team of about 2000 associates. Since all my sites are hosted at Host4Profit e
I have a team of about 2000 associates. Since all my sites are hosted at Host4Profit e
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
cept for the site that their websites are hosted on, I decided to transfer everything over. Well, I have transferred many sites be
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ore so I knew how it worked. I knew I would get access to Host4Profit before transferring with my registrar and that all I had to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
o was upload everything over to the new host while my old host was still active. This would make a seamless transfer. No one would
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
ever know anything happened ...
To make a long story short, it didn't turn out to be as seamless as I hoped and things were a lit
To make a long story short, it didn't turn out to be as seamless as I hoped and things were a lit
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
le messed up for about a day. Needless to say, I received TONS of emails!
"What happened?!"
"Where did you go?!"
"Give me my mo
"What happened?!"
"Where did you go?!"
"Give me my mo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ey back!"
"Hello? Are you there?"
Well, I couldn't ANSWER these emails because I was busy getting the transfer problem fixed. Th
"Hello? Are you there?"
Well, I couldn't ANSWER these emails because I was busy getting the transfer problem fixed. Th
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
s caused most of them to email me a SECOND time, therefore doubling the amount of emails sitting in my email box! Stress was build
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ng as I worked to get the problem fixed ....
After the problem was finally resolved, I sent an update letting everyone know what
After the problem was finally resolved, I sent an update letting everyone know what
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
appened. I got back to any emails that I felt needed answering ... this whole thing took almost 18 hours of my time and NO SLEEP f
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
r me!
The stress and the fact that I had no sleep took it's toll on me. When I got some really rude emails from some angry custom
The stress and the fact that I had no sleep took it's toll on me. When I got some really rude emails from some angry custom
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
rs and associates, I didn't take my own advice and let it sit until I calmed down. You know what I did instead? I gave refunds to
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
ll of them! I didn't even want to deal with it ... as a result, I refunded over $1000 in sales.
I know, I know ... you're asking
I know, I know ... you're asking
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
ourself, "How could that be a good thing?" Well, it made me get out of my bull stubborn "I'll handle it all" attitude and incorpor
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
te some much needed help. Now I have someone to answer those emails, someone to answer those calls, and various other things. What
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
a RELIEF! Why didn't I do it sooner?! :)
If you answered "Yes" to my first question above, heed my advice. Take off those bull h
If you answered "Yes" to my first question above, heed my advice. Take off those bull h
.
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
rns and find a couple of people that you trust to help with some of your dauntless duties. And if your business is not big enough
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
et to incorporate help and you're handling it just fine ... don't forget this advice when it grows right before your very eyes ---
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.justotherarticles.org.ua/article/4998/justotherarticles-A-Hard-Lesson-Learned.html">A Hard Lesson Learned....</a>
BB link (for phorums):
[url=http://www.justotherarticles.org.ua/article/4998/justotherarticles-A-Hard-Lesson-Learned.html]A Hard Lesson Learned....[/url]
Related Articles:
Super Size Your eBay Sales Using Buyer Psychology
Engraving Tools and Engraving Machines
Bookmark it:
|