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Advice You - The Law Of Physics Is Wrong
One law of physics tells us that for every action
there is an equal and opposite reaction.
Well I'm here to tell you that, in the case of the internet, that is all wrong.
There is nothing "equal" about the reactions of inte
Well I'm here to tell you that, in the case of the internet, that is all wrong.
There is nothing "equal" about the reactions of inte
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
rnet users!
You know what I mean if you've ever, for example, received an email from a friend (who received their email from a friend of a friend...) telling you "you may have a vir*us on your computer." These emails genera
You know what I mean if you've ever, for example, received an email from a friend (who received their email from a friend of a friend...) telling you "you may have a vir*us on your computer." These emails genera
; 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
lly include instructions on how to
remove some vital piece of necessary programming
from your operating system - something no sensible
person would ever do without investigating first.
Then... a few minutes or hours later, y
Then... a few minutes or hours later, y
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
u get a
second email, only this one is an apology. Your
friend is embarassed but willing to admit that
he/she was duped and now has in his/her possession
proof that the above WAS all "just a hoax."
In the meantime, the fir
In the meantime, the fir
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
st email caused a "gut
reaction." The receivers of the first initial
email, again without investigation, freaked out
and, wanting to make sure THEIR friends didn't
suffer a similar fate, emailed a whole new set
of internet
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sers to "watch out!"
They of course mailed their friends, who mailed their friends, who... you get the idea.
So I have proof positive that the law of reactionary physics as the scientists perceive it is all wrong!
There i
They of course mailed their friends, who mailed their friends, who... you get the idea.
So I have proof positive that the law of reactionary physics as the scientists perceive it is all wrong!
There i
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
s NO "equal reaction" on the internet - it
escalates all out of proportion quickly, easily,
efficiently.
TAKING A LOOK AT CURRENT EVENTS:
We are once again at that stage. The latest "out of proportion" action/reaction is th
TAKING A LOOK AT CURRENT EVENTS:
We are once again at that stage. The latest "out of proportion" action/reaction is th
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
e
internet's response to the "anti-sp*am" laws
going before the courts.
Normal, rational people in all walks of life with internet mailing lists are "reacting" perhaps totally out of proportion to this current state of aff
Normal, rational people in all walks of life with internet mailing lists are "reacting" perhaps totally out of proportion to this current state of aff
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
irs.
Now, don't get me wrong - there is legislation in the works to try to do something about all this junk we ALL are getting!
Bully for them, but if they'd done their own homework, the legislators would realize that a h
Now, don't get me wrong - there is legislation in the works to try to do something about all this junk we ALL are getting!
Bully for them, but if they'd done their own homework, the legislators would realize that a h
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
uge portion of this JUNK comes out of Asia,
from isps with absolutely NO INTEREST in
operating in an ethical fashion. These isps are
so well hidden that no amount of legislation from
all the countries in the universe is
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
oing to
make an iota of difference.
So while legislators react to lobbyists - without a hope of really ever making a difference - we've got the "regular Joe" online also over-reacting.
He or she thinks they are "doing the r
So while legislators react to lobbyists - without a hope of really ever making a difference - we've got the "regular Joe" online also over-reacting.
He or she thinks they are "doing the r
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
ight thing"
by conforming to laws that don't even exist yet.
And, in reality, these laws may never come to pass. Already challenges are being made through legal channels. These challenges may hold off any decision for years
And, in reality, these laws may never come to pass. Already challenges are being made through legal channels. These challenges may hold off any decision for years
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
to come.
Any sane person knows these attempts to make new laws will not work, but like anything it will takes years or decades of tying up the courts before anyone is going to admit it.
So are you going to just "react from
Any sane person knows these attempts to make new laws will not work, but like anything it will takes years or decades of tying up the courts before anyone is going to admit it.
So are you going to just "react from
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
the gut"
on this latest one - without researching,
without considering the fact that you may have
ALWAYS been doing business the right and ethical
way... without being told?
If you HAVE been collecting names and emails, a
If you HAVE been collecting names and emails, a
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
nd if they come with an isp identifier even
better - you've been doing it right all along.
The newest step to cover ones..., ah, you know, is to add a disclaimer at your signup site, and inside each mailing, that you run ads
The newest step to cover ones..., ah, you know, is to add a disclaimer at your signup site, and inside each mailing, that you run ads
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
These ads can be anything from programs you yourself are promoting to your downline, to the ezine publisher who runs his/her own ads and those of their subscribers.
Just be sure to tell would-be signer-uppers that they w
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
ill be getting ads from you and
their fellow downliners/subscribers/affiliates
if applicable.
That really covers it. Existing lists are people who've always been given numerous opportunities to leave that list at any given
That really covers it. Existing lists are people who've always been given numerous opportunities to leave that list at any given
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
time. Duh, they know they've been
getting ads... right?
Now just add in the "ad disclaimer" and be sure to always have the "click here to re*move yourself" link in all your mailings.
There, you are in essence "compliant."
Now just add in the "ad disclaimer" and be sure to always have the "click here to re*move yourself" link in all your mailings.
There, you are in essence "compliant."
.
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
I am not an attorney, and I'll be the first person to say things may change and evolve over time, but that is why doing your own homework is so vital - regardless of the latest happenings online.
More research - less "gut
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
reaction." Don't
rely on "what you've heard."
Be sensible, do YOUR OWN homework, apply what you learn, and make adjustments if needed. But don't destroy what you've built.
Adapt then react... with a proportional response
Be sensible, do YOUR OWN homework, apply what you learn, and make adjustments if needed. But don't destroy what you've built.
Adapt then react... with a proportional response
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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